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Suprapatellar Instrumentation forTitanium Cannulated Tibial Nail. Expert nailing system.

Technique Guide

Expert Nailing System

Introduction

Surgical Technique

Product Information

Table of Contents

Suprapatellar Instrumentation for Titanium 2Cannulated Tibial Nail Expert System

Titanium Cannulated Tibial Nail Expert System 4

AO Principles 6

Indications 7

Preoperative Planning 8

Opening the Tibia 9

Reaming (optional) 17

Inserting the Nail 19

Locking Options 24

Distal Locking 25

Proximal Locking—Diaphyseal and Distal Segment 31Fractures

Proximal Locking—Compression Locking Mode 35(Optional)

Proximal Locking—Proximal Segment Fractures 38

End Cap Insertion 45

Implant Removal (optional) 47

Implants 52

Instruments 62

Set Lists 70

Image intensifier control

SynthesSuprapatellar Instrumentation for Titanium Cannulated Tibial Nail Expert System Technique Guide

2 Synthes Suprapatellar Instrumentation for Titanium Cannulated Tibial Nail Expert System Technique Guide

Advanced instrumentationTwo-hole wire guides– Offset hole to “dial-in” placement of the guide wire

– Blunt tip

– Gentle transitions

Reusable PEEK opening trocars– Reusable solid design

– Smooth, rounded tip

– Gentle transitions

Steel inner protection sleeves– Suction holes

– Retention feature

– Finger grips for easy removal

– Protects soft outer sleeve during drilling and reaming

Handle– Retention knob

– Lever locks

– Through slot and holes to anchor handle

– Suction port

Soft outer protection sleeves– Soft, flexible material to cushion soft tissue

– Locks into handle with a ¼ turn

– Conforms to nail shape during insertion

Suprapatellar Instrumentation for Titanium Cannulated Tibial Nail–EXand Titanium Cannulated Tibial Nail–EX with Proximal Bend

Suprapatellar Instrumentation for Titanium Cannulated Tibial Nail Expert System Technique Guide Synthes 3

Insertion handle– Longer length for suprapatellar insertion

– Smaller diameter tip

– Smooth contoured reverse bevel for smooth transition

Aiming arm– Radiolucent material

– Protection sleeve retention

– Precise targeting

– Standard attachment mechanism

Extraction screw– Drill point tip

– Cutting flutes to remove debris

– Longer tip

Inter-lock screwdrivers– Locks into the recess of the screw

– Firm, mechanical locking mechanism

– Engages and disengages with the turn of a nut

Improved stability

Advanced solutionsAdvanced proximal locking options– Three innovative locking options, in

combination with dual core lockingscrews, to increase the stability of the proximal fragment for proximalthird fractures

– Two state-of-the-art mediolateral(ML) locking options enable primarycompression or secondary controlleddynamization

End caps– Gold end caps securely lock the most

proximal oblique locking screw tocreate a fixed-angle construct

– Gray end caps feature a lead-in design for easier end cap insertion

– End caps prevent ingrowth of tissueand facilitate nail extraction

– Self-retaining T40 StarDrive recess foreasy pick up and insertion of end cap

– Cannulated

– 0 mm end caps sit flush with nail

– 5, 10 and 15 mm end caps extend nail height if nail is overinserted


Titanium Cannulated Tibial Nail Expert System

StarDriveT40

15 mm 10 mm 5 mm 0 mm

15 mm 10 mm 5 mm 0 mm

Advanced nail design– New anatomic bend for ease of nail

insertion

– Titanium alloy* for improved mechanical and fatigue properties

– Cannulated nails (from 8 mm to 13 mm dia.) for reamed or unreamedtechniques, enabling nail insertionover guide wire

– All Synthes 2.5 mm or 3.0 mm balltipped guide wires may be removedthrough the nail and insertion handleassembly (no exchange tube required)

Advanced distal locking options– Distal oblique locking options to

prevent soft tissue damage and increase stability of the distal fragment

– Two ML and one anteroposterior (AP) locking options for stability of the distal fragment

All locking screws– Double-lead thread for more contact

points enhance stability and ease of insertion

– Thread closer to screwhead provides better bone purchase in the near cortex and improved stability

– Titanium alloy* for improved mechanical and fatigue properties

– Self-tapping blunt tip

– Self-retaining T25 StarDrive recess allows improved torque transmission and increased resistance to stripping relative to a hex recess and secure locking screw pick-up

Dual-core locking screws– Indicated for the three proximal

locking options of all tibial nails

– Dual-core design for optimized purchase in cancellous bone

– Unicortical

– Lengths: 30 mm–90 mm

Standard locking screws– Larger cross section for improved

mechanical resistance

– 4.0 mm diameter for 8 mm and 9 mmtibial nails, lengths: 18 mm–80 mm

– 5.0 mm diameter for 10 mm to 13 mmtibial nails, lengths: 26 mm–100 mm


Multidirectional locking options for improved stability

StarDriveT25

* Titanium-6% aluminum-7% niobium alloy

AO Principles


1. M.E. Müller, M. Allgöwer, R. Schneider, and H. Willenegger: Manual of Internal Fixation, 3rd Edition. Berlin: Springer-Verlag. 1991.

In 1958, the AO formulated four basic principles, which have become the guidelines for internal fixation.1 They are:

Anatomic reductionFracture reduction and fixation to restore anatomical relationships.

Stable fixationStability by fixation or splintage, as the personality of thefracture and the injury requires.

Preservation of blood supplyPreservation of the blood supply to soft tissue and bone by careful handling.

Early, active mobilizationEarly, active mobilization of the part and patient.

Indications

The Synthes Suprapatellar Insertion Instruments are part ofthe Synthes Tibial Nail System EX. The Synthes Tibial Nail System EX is intended to stabilize fractures of the proximaland distal tibia and the tibial shaft; open and closed tibialshaft fractures; certain pre- and post-isthmic fractures; andtibial malunions and non-unions.


Preoperative Planning

Use the AO preoperative planner template for the TibialNail–EX to estimate nail diameter and nail length.

To estimate nail diameter, place the template on the AP orlateral x-ray of the uninjured tibia and measure the diameterof the medullary canal at the narrowest part that will containthe nail.

To estimate nail length, place the template on the AP x-ray of the uninjured tibia and select the appropriate nail lengthbased on patient anatomy. When selecting nail size, considercanal diameter, indication, fracture pattern, patient anatomyand postoperative protocol.

Note: Templates are available in two sizes: actual size and115% magnification in which the image is enlarged 15% tocorrespond to typical radiographic magnification. However,variations in magnification levels are common.


2Reduce fracture

Instrument

394.35* Large Distractor

Perform closed reduction manually by axial traction under image intensification. The use of the large distractor may be appropriate in certain circumstances.

Notes:The reduction can be temporarily fixed with reductionclamps. In epiphyseal fractures the condyles or the pilon arefixed first in order to enable the nail insertion.

Alternative fracture reduction methods may be used such asblocking or poller screws, Schanz screws, or temporary plating.

Opening the Tibia


1Position patient

Position the patient supine on the radiolucent table. Ensurethat the knee of the injured leg can be flexed 10°-20°. Position the image intensifier so that visualization of thetibia, including the articular surface proximally and distally, is possible in AP and lateral views.

Note: The knee roll can be placed under the lower part of the thigh if it obstructs the view of the tibial plateau in the AP view.

* Also available

Opening the Tibia

3Confirm nail length and diameter

Instrument

03.010.021 Radiographic Ruler, for Titanium CannulatedTibial Nails–EX

The required nail length must be determined after reductionof the lower leg fracture.

Position the C-arm for an AP view of the distal tibia. Withlong forceps, hold the radiographic ruler along the leg, parallel to and at the same level as the tibia. Adjust the ruleruntil the distal tip is at the level of the physeal scar or the desired nail insertion depth. Mark the skin at that site.



Move the C-arm to the proximal tibia, replace the distal endof the ruler at the skin mark, and take an AP image of theproximal tibia. Read nail length directly from the ruler image,selecting the measurement at or just below the level of theanterior edge of the tibial plateau.

When using the large distractor, measure the distance fromthe inferior border of the distal pin to the superior border ofthe proximal pin to determine optimal nail length.

Position the C-arm for an AP or lateral view of the tibia at the level of the isthmus. Hold the radiographic ruler over the tibia with the diameter gauge centered over the narrowest part of the medullary canal. Read the diametermeasurement on the circular indicator that fills the canal.

Note: Compression or dynamization must be taken into account when determining the nail length. A shorter nailshould be chosen when active compression is planned forthe procedure. The dynamic locking option allows 7 mm of travel.

Important: The ruler is not at the same level as the tibia. This affects the accuracy of the measurement, providing only an estimate of the canal diameter.

Opening the Tibia


4Make incision and determine entry point

With the knee in full extension, make a 2–4 cm longitudinalskin incision 4 cm proximal to the superior pole of the patella.The deep incision, also longitudinal, splits the quadriceps tendon in its midsubstance, just above its insertion into thepatella and enters the knee joint through the suprapatellarpouch. Blunt dissection can be used to loosen the patella in the suprapatellar pouch, allowing the patella to lift off.Displace the patella anteriorly.

Note: In arthritic knees, blunt release with an elevator orcauterization can be done in the suprapatellar pouch areamedially and laterally.

If these methods are not sufficient, extend the incision medially or laterally along the patella.

The entry point defines the optimal position of the nail in theintramedullary canal. This is more important for proximal anddistal-third fractures to prevent fragment displacement.

In the AP view the entry point is in line with the axis of the intramedullary canal and with the lateral tubercle of the intercondylar eminence.

In the lateral view the entry point is at the ventral edge of thetibial plateau.

Entry point

10°

Entry point


5Insert protection sleeves

Instruments

03.010.430 Handle for Protection Sleeves, for Suprapatellar

For 8 mm to 11 mm nails:03.010.435 12.0 mm Protection Sleeve, straight,

for 8 mm–11 mm nails

03.010.437S 12.0 mm Outer Protection Sleeve, for suprapatellar, sterile

and03.010.455 12.0 mm Trocar, PEEK, for Suprapatellar

For 12 mm to 13 mm nails:03.010.436 14.5 mm Protection Sleeve, straight,

for 12 mm–13 mm nails


and

03.010.456 14.5 mm Trocar, PEEK, for Suprapatellar

Assemble the inner protection sleeve to the handle from thetop. The inner protection sleeve locks into place with the twolever locks on the sides of the handle. Insert the trocar throughthe inner protection sleeve. Rotate the black knob to hold inplace. Dip the outer protection sleeve and inner protectionsleeve in saline solution before assembly. Slide the outer protection sleeve over the inner protection sleeve from thebottom. Line up the tabs on the outer protection sleeve withthe notches on the handle. Rotate clockwise to attach to the handle.

4.3 mm

Opening the Tibia


6Insert guide wire

Instruments

03.010.433 Wire Guide, 2 holes, 12.0 mm/3.2 mmor03.010.434 Wire Guide, 2 holes, 14.5 mm/3.2 mm

357.399 3.2 mm Guide Wire, 400 mm

After removal of the trocar, insert the two-hole wire guidethrough the inner protection sleeve. Advance to the anteriorsurface of the tibia. Slight adjustment of the knee flexion(between 10° and 20°) will provide the ideal radiographic location for the starting point and insertion of a guide wire.

Insert the guide wire approximately 8 cm–10 cm and checkthe position under imaging in the AP and lateral views.

Adjustments to the guide wire location can be “dialed-in” by rotating the two-hole drill guide to place a second guidewire while the first guide wire remains in place. After correctplacement of the second guide wire, remove the initial guidewire and two-hole wire guide.


7Anchor handle for protection sleeves

Instrument

357.399 3.2 mm Guide Wire, 400 mm

Use a 3.2 mm guide wire to anchor the handle assembly tothe femoral condyles and maintain the position of the handleassembly during the procedure. This anchor prevents thecannula from backing out and off of the tibia.

Alternative instrument

03.010.115 3.2 mm Guide Wire, 290 mm

310.243 2.5 mm Drill Tip Guide Wire, 200 mm

292.75 2.5 mm Kirschner wire with 15 mm threaded trocar point, 150 mm

Opening the Tibia


8Open medullary canal

Instruments

03.010.439 12.0 mm Cannulated Drill, long, with largequick coupling

357.399 3.2 mm Guide Wire, 400 mm

Place the drill bit over the guide wire, through the inner protection sleeve, and down to the bone. Drill to a depth of approximately 8 cm–10 cm. The guide wire and drill bitshould not reach the posterior cortex.

Remove the drill bit and guide wire.

Note: Dispose of the guide wire. Do not reuse.


Reaming (optional)

Instruments

03.010.024 Holding Device, for guide wires and reamingrods

03.010.093 Reaming Rod Push Rod, with ball handle

2.5 mm Reaming Rods, sterile351.704S* with ball tip and extension, 1150 mm351.706S* with ball tip, 950 mm351.707S* with ball tip and extension, 950 mm351.708S* with ball tip, 1150 mm

352.044 5.0 mm Flexible Shaft, 620 mm

393.105* Small Universal Chuck with T-Handle

Note: If inserting a nail 330 mm or longer, the 5.0 mmFlexible Reamer Shaft, 620 mm (352.044) must be used.

Also available sets

01.004.306 Flexible Reamer Set, long for IM nails

150.060 Flexible Reamer Set, for IM nails

If necessary, enlarge the tibial canal to the desired diameter,using the medullary reamer.

Check fracture reduction under radiographic imaging.

Warning: Do not ream without the inner protection sleevein place to protect the outer protection sleeve.

* Also available


Inserting the reaming rodUsing the holding device, insert the reaming rod with ball tipinto the medullary canal to the desired depth.

ReamStarting with the 8.5 mm diameter reaming head, ream to a diameter of 0.50 mm–1.0 mm greater than the nail diameter.

Ream in 0.5 mm increments and advance the reamer with steady, moderate pressure. Do not force the reamer. Partially retract the reamer often to clear debris from the medullarycanal.

Note: All nails in the cannulated Tibial Nail Expert System can be inserted over the reaming rod with ball tip.

If a nail length greater than 330 mm is required, the long 5.0 mm flexible shaft must be used.

Technique tip: The reamer can catch on the edge of the inner protectionsleeve because of the sharp angle entering the tibia (Figure 1). Stop reamer rotation and lift up on the drill to center the reamer shaft in the sleeve (Figure 2). Move the reamer in and out until the reamer comes out.

Optional techniqueUse the reaming rod push rod to help retain the reaming rodduring reamer extraction.

Reaming (optional)

Figure 1: Reamer shaft angled through sleeve.

Figure 2: Reamer shaft centered through sleeve.

Inserting the Nail

1Assemble insertion instruments

Instruments


03.010.404 Cannulated Connecting Screw, forPercutaneous Instruments for Nails–EX

03.010.440 Insertion Handle, for suprapatellar

Orient the insertion handle anteriorly, and match the tang on the handle to the notch in the nail.

Place the connecting screw into the insertion handle andthread it into the proximal nail end, using the reaming rodpush rod.

Verify the nail is oriented properly on the insertion handle; secure the assembly with the reaming rod push rod.


03.010.092 Ball Hex Screwdriver, 8 mm

Optionally, secure the assembly using the 8 mm ball hexscrewdriver.

Remove inner protection sleeve from handle for protectionsleeves.

Technique tip:When removing the inner protection sleeve, lift or rotatehandle to gain access to the lower lever lock. Depress bothupper and lower lever locks and slide the inner protectionsleeve out.

Note: If the knee is tight, the pressure on the sleeve willmake it difficult to remove the inner protection sleeve.


Inserting the Nail

2Insert nailEnsure inner protection sleeve is removed.

Insert the nail into the intramedullary canal. Use a twistingmotion to advance the nail.

Monitor the nail passage across the fracture; control in twoplanes to avoid malalignment.

Insert the nail until it is at or below the tibial opening. Check final nail position in AP and lateral views.

Note: For proximal locking, mount the aiming arm onlywhen the tibial nail has been completely inserted, otherwisethe aiming arm may loosen during nail insertion.

Optional instruments

03.010.056 Slide /Fixed Hammer, 700 grams

03.010.475 Driving Cap

321.17 4.5 mm Pin Wrench

321.20 Ratchet Wrench, 11 mm width across flats

357.22 Hammer Guide, for slide hammer

357.398 Cannulated Shaft with 8 mm hex

If needed, use light, controlled hammer blows to seat the nail.Thread the driving cap into the insertion handle and secureit, using the 11 mm wrench. Lock the head of the hammer in place by tightening the nut onto the threads located belowthe hammer head, using the 4.5 mm pin wrench. Strike thedriving cap directly.

Optionally, the hammer guide can be threaded into the driving cap and the hammer can be used as a slide hammer.The hammer guide helps to assure the driving cap is struckoptimally. Loosen the nut from the threads located below thehammer head and secure onto the threads located above the handle.


Notes:If nail insertion is difficult, choose a smaller diameter tibialnail or ream the medullary canal to a larger diameter. Ifreaming to a larger diameter, assemble the two-hole wireguide into the inner protection sleeve. Insert this assemblythrough the handle and into the outer protection sleeve.Often the outer protection sleeve is flattened by the pressureof the patella and the wire guide helps to expand the sleeveas the inner protection sleeve is reinserted. This also reducesthe potential of the inner protection sleeve damaging theouter protection sleeve.


Inserting the Nail


3Check proximal nail position

Instruments

03.010.441 Aiming Arm, for suprapatellar

357.399 3.2 mm Guide Wire, 400 mm

Attach the aiming arm and insert a 3.2 mm guide wirethrough the hole as shown in the illustration.

The tip of the guide wire indicates the exact proximal positionof the tibial nail.

Remove the driving cap.

Remove the aiming arm, unless proximal locking is the nextstep.

Check proximal nail position under image intensification in the lateral view.

Note: The distance between the markings on the insertionhandle is 5 mm and corresponds to the extensions of theend caps. This feature can be used for overinsertion of thenail or for correcting the nail location within the medullarycanal.

If primary compression or secondary dynamization isplanned, it is recommended to overinsert the nail by morethan 7 mm, which corresponds to the maximum distancebetween the positions in static and dynamic modes.


4Check distal nail position

Instruments


03.010.444 8 mm Hex Screwdriver, cannulated, inter-lock

03.010.445 SD40 StarDrive Screwdriver, long, inter-lock

Check final nail position under image intensification in AP and lateral views.

Remove the reaming rod.

Important: Confirm that the nail is securely connected to the insertion handle, especially after hammering, using eitherthe 8 mm ball hex screwdriver or the cannulated shaft with 8 mm hex screwdriver, cannulated, interlock.

Note: Insertion depth is critical for distal third fractureswhere a minimum of two locking screws below the fractureline are required to stabilize the distal segment.

Locking Options

Proximal segment fracturesProximal locking using the suprapatellar technique is per-formed with the knee in extension. This neutralizes the deforming forces on proximal fragments caused by thequadriceps mechanism, and relieves the pressure on thesoft tissue usually associated with tibial nail insertion instruments. This position also facilitates assessment of rotational alignment before locking.

Diaphyseal segment fracturesFor diaphyseal fractures, it is recommended to lock distallyfirst, to allow intraoperative compression.

Distal segment fracturesFor distal fractures, it is recommended to lock distally first, to facilitate reduction.



Distal Locking

1Determine instrumentation

Instruments

03.010.404 Cannulated Connecting Screw, forPercutaneous Instruments for Nails–EX

03.010.440 Insertion Handle for suprapatellar

511.30* Radiolucent Drive

Use the appropriate locking screws and drill bit for the nail diameter selected.

Nail diameter Locking screw Drill bit

8 mm and 9 mm 4.0 mm 3.2 mm(blue) (blue) 03.010.100** or

03.010.103

10 mm to 13 mm 5.0 mm 4.2 mm(green) (green) 03.010.101** or

03.010.104

If using the backslap technique,† distal locking must be per-formed prior to proximal locking to prevent loss of reduction. Verify the nail has been inserted to the appropriate depth.

Locking of the tibial nail is usually performed from the medialside. The knee must be in extension during nail locking. Thisposition helps counteract the forces exerted by the quadricepsmuscle that would tend to deform the proximal fragment andalso facilitates rotational control of the tibial axis before locking.

Distal locking with the radiolucent drive is described on page 27.

Note: The use of the most distal locking option is recom-mended for distal fractures. This locking option is oriented30° from the sagittal plane.

* Also available** For radiolucent drive† See page 21.

Distal Locking

2Align image

Check the reduction, correct alignment of the fragments, and leg length before locking the nail.

Align the C-arm with the hole in the nail closest to the fracture until a perfect circle is visible in the center of thescreen. (Distal ML hole shown in illustration).

3Determine incision point

Place a guide wire on the skin over the center of the hole tomark the incision point and make a stab incision.


4Drill

Instruments

03.010.100* 3.2 mm Three-Fluted Drill Bit, 145 mm, forRadiolucent Drive


Using the radiolucent drive under radiographic imaging, insertthe tip of the appropriate drill bit through the incision anddown to the bone.

Incline the drive so that the tip of the drill bit is centered overthe locking hole. The drill bit should almost completely fillthe circle of the locking hole. Hold the drill bit in this positionand drill through both cortices.

Technique tip: For greater drill bit control, discontinue drillpower after perforating the near cortex. Manually guide thedrill bit through the nail before resuming power to drill thefar cortex.

Alternative instruments

03.010.103 3.2 mm Three-Fluted Drill Bit, quick coupling,145 mm


Standard freehand locking technique can be performedwithout the radiolucent drive. Use the appropriate drill bitshown above.


* Also available

Distal Locking

5Determine locking screw length

Instruments





03.010.106 Direct Measuring Device, for locking screws to 100 mm, for IM nails

Stop drilling immediately after both cortices and disassemblethe drill bit from the radiolucent drive.

Ensure the correct position of the drill bit beyond the far cortexunder radiographic imaging.

Place the direct measuring device onto the drill bit. Read thegraduation of the measuring device at the end of the drill bit.This corresponds to the appropriate locking screw length.

Note: Drill bit location with respect to the far cortex is criticalfor measuring the appropriate locking screw length.


* Also available


03.010.072 Depth Gauge, forlocking screws to100 mm, for IM nails

Measure the locking screw length using the depth gauge for lockingscrews. Ensure the outer sleeve is incontact with the bone and the hookgrasps the far cortex.

Read the locking screw length directlyfrom the depth gauge at the back ofthe outer sleeve.


Distal Locking

6Insert locking screw

Instruments

03.010.107 StarDrive Screwdriver, T25, self-retaining

03.010.112 Holding Sleeve, with locking device

Insert the appropriate length locking screw using the T25StarDrive screwdriver and the holding sleeve with locking device, if needed.

Verify locking screw length under image intensification. Ifneeded, a second locking screw may be inserted using thesame technique.

Note: If compression is desired, the backslap technique* canbe used after insertion of the second distal locking screw. Alternatively, the compression device can be used, refer topages 35 and 36.

Use the holding sleeve as described below:

a Insert the holding sleeve onto the shaft of the screwdriverand place the tip of the screwdriver in the recess of thelocking screw.

b Push the holding sleeve in the direction of the locking screw,the sleeve now holds the locking screw.

c Lock the holding sleeve by tightening it counterclockwise.

d Release the holding sleeve after insertion of the lockingscrew, by loosening it clockwise and pushing backwards.


03.010.472 Inter-lock Screwdriver, StarDrive, 2.5 /3.5 mm hex, 330 length


* Backslap technique: with the hammer guide attached to the driving cap andinsertion handle (see page 21) light, reverse hammer blows may be used tocompress the fracture; monitor reduction radiographically.

a

b

c

d

Proximal Locking— Diaphyseal and Distal Segment Fractures

1Choose locking screws and instruments

Use the correct locking screw, drill sleeve, trocar and drill bitfor the selected nail diameter, as shown in the table.

Three proximal ML locking options can be targeted using the aiming arm:

1 The dynamic locking option (DYNAM) corresponds to the upper position of the proximal locking slot. This type of locking allows primary compression or secondary, controlled dynamization of the bone fragments.

2 Static 2 (STAT 2) corresponding to the lower position ofthe proximal locking slot. This type of locking does not allow primary compression or secondary controlled dynamization.

3 Static 1 (STAT 1) corresponding to most distal proximallocking hole.


Nail diameter Locking screws Protection sleeve Drill sleeve Trocar Calibrated drill bit

8 mm and 9 mm 4.0 mm 12.0 mm/8.0 mm 8.0 mm/3.2 mm 3.2 mm 3.2 mm(blue) (blue) with flats 03.010.064 03.010.069 03.010.060

03.010.442

10 mm–13 mm 5.0 mm 12.0 mm/8.0 mm 8.0 mm/4.2 mm 4.2 mm 4.2 mm(green) (green) with flats 03.010.065 03.010.070 03.010.061

03.010.442

DYNAM

STAT 2

STAT 1


2Mount aiming arm

Instrument


Confirm that the nail is securely connected to the insertionhandle using the 8 mm ball hex. Mount the aiming arm tothe insertion handle.

Note: Do not exert forces on the aiming arm, protectionsleeve, drill sleeves and drill bits. These forces may preventaccurate targeting through the proximal locking holes anddamage the drill bits.

3Insert trocar assembly

Instruments

03.010.064 8.0 mm/3.2 mm Drill Sleeve, 200 mm (with blue and gold marking)

03.010.065 8.0 mm/4.2 mm Drill Sleeve, 200 mm (with green marking)

03.010.069 3.2 mm Trocar, 210 mm (with blue and goldmarking)

03.010.070 4.2 mm Trocar, 210 mm (with green marking)

03.010.442 12.0 mm / 8.0 mm Protection Sleeve with flats

Insert the three-part trocar assembly (protection sleeve, corresponding drill sleeve and trocar) through the desired ML hole in the aiming arm, make a stab incision and insert the trocar to the bone. Remove the trocar.


4Drill and determine locking screw length

Instruments

03.010.060 3.2 mm Three-Fluted Drill Bit, quick coupling,330 mm, 100 mm calibration (with blue andgold marking)

03.010.061 4.2 mm Three-Fluted Drill Bit, quick coupling,330 mm, 100 mm calibration (with greenmarking)

Ensure that the drill sleeve is pressed firmly to the near cortex.Using the corresponding drill bit (3.2 mm for 4.0 mm lockingscrews, or 4.2 mm for 5.0 mm locking screws), drill through bothcortices until the tip of the drill bit penetrates the far cortex.

Confirm drill bit position under radiographic imaging.

Ensure that the drill sleeve is pressed firmly to the near cortexand read the measurement from the calibrated drill bit at theback of the drill sleeve. This measurement corresponds to theappropriate length locking screw. Remove the drill bit andthe drill sleeve.


03.010.072 Depth Gauge, for locking screws to 100 mm, for IM nails

After drilling both cortices, remove the drill bit and the drill sleeve.

Disassemble the depth gauge into two parts: the outer sleeveand the measuring device with hook. Insert the measuringdevice into the protection sleeve. Make sure that the hookgrasps the far cortex and that the protection sleeve is on the bone.

Read the measurement from the back of the protection sleeve,which indicates the appropriate length locking screw.



5Insert locking screw

Instrument


Insert the appropriate length locking screw through the protection sleeve using the T25 StarDrive screwdriver. Verify locking screw length under image intensification.

The tip of the locking screw should not project more than 1 mm–2 mm beyond the far cortex.

Repeat the Steps 3 to 5 for the second proximal ML locking screw.

Option Additional dual core locking screws can be added for proximal fractures and highly unstable fractures.

Refer to pages 38–44 for details on proximal locking withthe dual core locking screws.




Proximal Locking— Compression Locking Mode (Optional)

1Compression locking mode (optional)

If the fracture gap needs compression after nail insertion, it can be accomplished without removing the insertion instruments.

The Tibial Nail–EX allows a maximum compression of 7 mm. If more compression of the fracture gap is needed,the conventional backslap technique is recommended (see page 21).

Note: Distal locking is required prior to compression locking,refer to page 25.

Insert one proximal locking screw in the dynamic locking hole(DYNAM). Refer to Diaphyseal and Distal Segment Fractures(page 31) for details on inserting this locking screw.


Proximal Locking—Compression Locking Mode (optional)


2Insert compression device

Instruments


03.010.443 Compression Device, for suprapatellar, for usewith (03.010.404) and (03.010.440)

Confirm that the nail is securely connected to the insertionhandle using the 8 mm ball hex screwdriver.

Insert the compression device through the connecting screwand into the nail using the 8 mm ball hex screwdriver.

The compression device will contact the dynamic locking screw.

Advance the compression device until the fracture gap is reduced. Monitor reduction under image intensification.Each revolution of the compression device corresponds tocompression of 1 mm (maximum 7 mm).

Important: Do not overtighten the compression device, it may deform the locking screw.


4Insert static locking screw

Insert second proximal locking screw in the most distal holeof the proximal locking options (Static 1). Refer to section Diaphyseal and Distal Segment Fractures.

Remove the compression device.

Additional oblique dual core locking screws can be inserted if required. Refer to Proximal Segment Fractures (pages38–44).

3Monitor fracture

Control the fracture gap before, during, and after the compression procedure.

Proximal Locking— Proximal Segment Fractures


Proximaloblique

A/P oblique

Distal oblique

1Oblique proximal locking

Instruments

03.010.404 Cannulated Connecting Screw forPercutaneous Instruments for Nails–EX

03.010.440 Insertion Handle for Suprapateller

Proximal locking is performed with the knee in extension whenusing the suprapatellar technique. This neutralizes the deform-ing forces on proximal fragments caused by the quadricepsmechanism and relieves the pressure on the soft tissue usuallyassociated with tibial nail insertion instruments. This positionalso facilitates assessment of rotational alignment prior to locking.

Note: When locking with the leg in full extension it is recommended to use the Tibial Nail–EX insertion handle and cannulated connecting screw to prevent impingementon the patella. These devices are not compatible with thecompression device.

The aiming arm can target all three proximal oblique locking options:

1 The oblique locking option (PROXIMAL OBLIQUE) corre-sponds to the most proximal locking position. Inserting a tibial nail end cap with this locking screw will create afixed-angle construct.

2 The oblique locking option (DISTAL OBLIQUE) corresponds to the second proximal locking position.

3 The oblique locking option in anteroposterior direction(A/P) corresponds to the third proximal locking position.


Common peroneal nerve

Poplitealartery

Tibialnerve

Use the dual core locking screws (gold) only in combinationwith the two oblique proximal locking holes (PROXIMALOBLIQUE, DISTAL OBLIQUE) and A/P proximal locking hole for all nail diameters.

Use a 3.2 mm drill bit for the 5.0 mm dual core locking screws.

Important: Drilling for the oblique proximal locking screwsrequires special attention. To avoid lesion of the popliteal artery, the tibial nerve and the common peroneal nerve, aswell as damage to the proximal tibiofibular joint, drilling mustbe stopped immediately before penetrating the far cortex.

Proximal Locking— Proximal Segment Fractures

2Mount aiming arm

Instruments



Confirm that the nail is securely connected to the insertionhandle using the 8 mm ball hex screwdriver. Mount the aimingarm to the insertion handle as shown in the illustration.

Note: Do not exert forces on the aiming arm, protectionsleeve, drill sleeves and drill bits. These forces may prevent accurate targeting through the proximal locking holes anddamage the drill bits.


3Insert trocar assembly

Instruments

03.010.064 8.0 mm/3.2 mm Drill Sleeve, 200 mm (with blue and gold marking)

03.010.069 3.2 mm Trocar, 210 mm (with blue and gold marking)

03.010.442 12.0 mm/8.0 mm Protection Sleeve, withflats for suprapatellar

Insert the three-part trocar assembly (protection sleeve, cor-responding drill sleeve and trocar) through the desired holefor oblique locking options in the aiming arm, make a stab incision and insert the trocar to the bone. Remove the trocar.

4Drill and determine dual core locking screw length

Instrument

03.010.060 3.2 mm Three-Fluted Drill Bit, quick coupling,330 mm, 100 mm calibration (with blue andgold marking)

Ensure that the drill sleeve is pressed firmly to the nearcortex.

Insert the calibrated drill bit and start drilling the near cortex.

Stop drilling immediately after penetrating the nearcortex. DO NOT penetrate the far cortex.


Proximal Locking—Proximal Segment Fractures

Monitor the position of the drill bit with image intensification.This can be done by orienting the image intensifier perpendi-cular to the drill bit.

Drill to the desired depth. A long dual core locking screw will achieve better bone purchase than a shorter dual corelocking screw.

Important: Do not perforate the far cortex with the drill bit.Do not damage the tibial plateau.


Confirm drill bit position after drilling under image intensifi-cation.

Ensure that the drill sleeve is pressed firmly to the bone andread the measurement from the calibrated drill bit at theback of the drill sleeve.

This measurement indicates the appropriate length of thedual core locking screw.

Remove the drill bit and the drill sleeve.

Important: To avoid perforation of the far cortex with thedual core locking screw, a dual core locking screw 5 mmshorter than the measured length is recommended.

5Insert dual core locking screws

Instrument


Insert the appropriate 5.0 mm dual core locking screw throughthe protection sleeve, using the T25 StarDrive screwdriver.Do not overtighten.

Verify locking screw length under image intensification.

Repeat this procedure for the second dual core locking screw.




Proximal Locking—Proximal Segment Fractures

Option Repeat the steps described above for the third proximal dualcore locking screw in the AP direction.

The position of the dual core locking screw should be controlled under image intensification to ensure a correct position of the AP dual core locking screw.


End Cap Insertion

Instrument


All titanium end caps for the Tibial Nail–EX are available in extension lengths of 0 mm, 5 mm, 10 mm, and 15 mm.They prevent bone ingrowth into the nail and they extendthe nail height if it is overinserted.

The gold end caps lock the proximal oblique screw providinga stable, fixed-angle construct.

The gray end caps have a lead-in design for easier insertion.These are only used for standard transverse proximal locking.The two proximal oblique locking holes cannot be used withthe gray end caps.

Alternative instruments

03.010.447 SD40 StarDrive Screwdriver, long, cannulated

357.399 3.2 mm Guide Wire, 400 mm

The end caps are cannulated for use over a guide wire, if necessary.

Remove the connecting screw. The insertion handle can re-main in place to help align the end cap to the top of the nail.The end cap fits through the barrel of the insertion handle.

Alternatively, remove the connecting screw and insertionhandle. Reinsert the inner protection sleeve to open the cannula through the outer protection sleeve.


End Cap Insertion

Engage the end cap with the cannulated SD40 StarDrivescrewdriver, inter-lock. To prevent cross threading, align the end cap with the nail axis and turn the end capcounterclockwise, until the thread of the end cap aligns with that of the nail.

Turn the end cap clockwise to thread the end cap into the nail.

Remove the guide wire and T40 StarDrive screwdriver.

Note: The end cap will engage the most proximal obliquelocking screw to create a fixed-angle construct.


Implant Removal (Optional)

1Remove end cap and locking screws

Instruments




03.010.447* SD40 StarDrive Screwdriver, long, cannulated

Note: Implant removal may be performed through a standardapproach or a suprapatellar approach. The suprapatellar approach is shown for illustrative purposes only.

Clear the StarDrive socket of the end cap and the locking implants of any tissue ingrowth. Remove the end cap withthe long inter-lock SD40 StarDrive screwdriver.

Remove all locking screws except one of the proximal locking screws, using the T25 StarDrive screwdriver andholding sleeve.

Note: Always remove the most proximal dual core lockingscrew in order to insert the extraction screw into the proximalend of the Tibial Nail–EX.


* Also available


2Attach extraction screw and hammer guide

Instruments


03.010.446 Extraction Screw/M8, for suprapatellar

357.22 Hammer Guide

Before removing the final locking screw, screw the extractionscrew into the tibial nail and tighten it to prevent rotation ordisplacement of the nail posteriorly below the tibial plateau.

Attach the hammer guide to the extraction screw.

Remove the remaining locking screw with the T25 StarDrive screwdriver.

3Remove nail

Instrument


Extract the nail by applying gentle blows with the hammer.



Alternative Technique–Extraction Hook

For removal of broken nail

Instruments

355.399◊ Extraction Hook, for Titanium Cannulated Nails

393.10 Universal Chuck with T-Handleor393.105 Small Universal Chuck with T-Handle

1Clear tissue from the end of the nail and remove the end cap.

2Remove the locking bolts and/or screws with the appropriatescrewdriver.

3Insert the extraction hook into the universal chuck with T-handle.The hook should be parallel with the T-handle. This facilitatesvisualization of the hook position in the bone.

◊ Available nonsterile or sterile-packed. Add “S” to catalog number to order sterile product.



4Attach the appropriate extraction bolt or connecting screwto the nail. Remove the near nail fragment using the extrac-tion bolt or the connecting screw.

Note: The extraction hook can be used as an alternative tothe extraction screw.

5Ream the medullary canal 1 mm larger than the diameter ofthe nail to clear a path for the distant nail fragment.

6Insert the extraction hook and explanted, near nail fragmentinto the medullary canal. The near nail fragment aligns the extraction hook with the cannulation of the distal nail fragment.

7Pass the extraction hook through the cannula of the distantnail fragment.

Note: Under image intensification, verify that the hook haspassed through and engaged the distal end of the nail.

8Extract both nail fragments.

Note: Keep the patient’s limb restrained to increase the efficiency of the extraction force.


For removal of an intact nail

Instruments

355.399◊ Extraction Hook, for Titanium Cannulated Nails

393.10 Universal Chuck with T-Handleor393.105 Small Universal Chuck with T-Handle

1Clear tissue from the end of the nail and remove the end cap.

2Remove the locking bolts and/or screws with the appropriatescrewdriver.

3Insert the extraction hook into the universal chuck with T-handle. The hook should be parallel with the T-handle. This facilitates visualization of the hook position in the bone.

4Insert the extraction hook through the nail cannula.

Note: Under image intensification, verify that the hook haspassed through and engaged the distal end of the nail.

5Extract the nail.

Note: Keep the patient’s limb restrained to increase the efficiency of the extraction force.



14 mm20 mm

30 mmDistalOblique

ProximalOblique

AP

36 mm

7 mm

5 mm

22 mm

AP

Oblique

37 mm

ML

ML

13 mm

57 mm

Implants

Titanium Cannulated TibialNails–EXUniversal design for the left or righttibia

MaterialTitanium-6% aluminum-7% niobiumalloy

Diameters8 mm–13 mm (1 mm increments)– 8 mm–10 mm nails have a proximal

diameter of 11 mm

– 11 mm–13 mm nails have a proximal diameter consistent with the shaft diameter

Colors– 8 mm and 9 mm (blue) use 4.0 mm

titanium locking screws (blue)

– 10 mm–13 mm (green) use 5.0 mm titanium locking screws (green)

Lengths255 mm–435 mm (15 mm increments)

Cross section– 8 mm–10 mm nails are round

– 11 mm–13 mm nails are fluted

Stat 1

Stat 2Dynamic

Start of bendis 75 mm

10.5º

End of bendis half lengthof nail

Radius varies


8 mm9 mm

11 mm12 mm13 mm

10 mm

Titanium Cannulated Tibial Nails–EX, sterile*

Length 8 mm dia. 9 mm dia. 10 mm dia.(mm) dark blue dark blue light green255 04.004.231S 04.004.331S 04.004.431S 270 04.004.234S 04.004.334S 04.004.434S 285 04.004.237S 04.004.337S 04.004.437S 300 04.004.240S 04.004.340S 04.004.440S 315 04.004.243S 04.004.343S 04.004.443S 330 04.004.246S 04.004.346S 04.004.446S 345 04.004.249S 04.004.349S 04.004.449S 360 04.004.252S 04.004.352S 04.004.452S 375 04.004.255S 04.004.355S 04.004.455S 390 04.004.258S 04.004.358S 04.004.458S 405 04.004.261S 04.004.361S 04.004.461S 420 04.004.264S 04.004.364S 04.004.464S 435 04.004.267S 04.004.367S 04.004.467S

Length 11 mm dia. 12 mm dia. 13 mm dia.(mm) light green light green light green255 04.004.531S 04.004.631S 04.004.731S270 04.004.534S 04.004.634S 04.004.734S285 04.004.537S 04.004.637S 04.004.737S300 04.004.540S 04.004.640S 04.004.740S315 04.004.543S 04.004.643S 04.004.743S330 04.004.546S 04.004.646S 04.004.746S345 04.004.549S 04.004.649S 04.004.749S360 04.004.552S 04.004.652S 04.004.752S375 04.004.555S 04.004.655S 04.004.755S390 04.004.558S 04.004.658S 04.004.758S405 04.004.561S 04.004.661S 04.004.761S420 04.004.564S 04.004.664S 04.004.764S435 04.004.567S 04.004.667S 04.004.767S

* Titanium-6% aluminum-7% niobium alloy

Implants


14 mm20 mm

30 mmDistalOblique

Proximal Oblique

AP

36 mm

7 mmStat 2

Dynamic

Stat 1

5 mm

22 mm

AP

Oblique

37 mm

ML

ML

13 mm

57 mm

Titanium Cannulated TibialNails–EX with proximal bendUniversal design for the left or righttibia

MaterialTitanium-6% aluminum-7% niobiumalloy

Diameters8 mm–13 mm (1 mm increments)– 8 mm–10 mm nails have a proximal

diameter of 11 mm

– 11 mm–13 mm nails have a proximal diameter consistent with the shaft diameter

Colors– 8 mm and 9 mm (blue) use 4.0 mm

titanium locking screws (blue)

– 10 mm–13 mm (green) use 5.0 mm titanium locking screws (green)

Lengths255 mm– 435 mm (15 mm increments)

Cross Section– 8 mm–10 mm nails are round

– 11 mm–13 mm nails are fluted

Start of bendis 65 mm

10.5º

Start of 3º tipbend is 57 mm

R 100


8 mm9 mm

11 mm12 mm13 mm

10 mm

Titanium Cannulated Tibial Nails–EX with proximalbend, sterile

Length 8 mm dia. 9 mm dia. 10 mm dia.(mm) dark blue dark blue light green255 04.034.231S 04.034.331S 04.034.431S 270 04.034.234S 04.034.334S 04.034.434S 285 04.034.237S 04.034.337S 04.034.437S 300 04.034.240S 04.034.340S 04.034.440S 315 04.034.243S 04.034.343S 04.034.443S 330 04.034.246S 04.034.346S 04.034.446S 345 04.034.249S 04.034.349S 04.034.449S 360 04.034.252S 04.034.352S 04.034.452S 375 04.034.255S 04.034.355S 04.034.455S 390 04.034.258S 04.034.358S 04.034.458S 405 04.034.261S 04.034.361S 04.034.461S 420 04.034.264S 04.034.364S 04.034.464S 435 04.034.267S 04.034.367S 04.034.467S

Length 11 mm dia. 12 mm dia. 13 mm dia.(mm) light green light green light green255 04.034.531S 04.034.631S 04.034.731S270 04.034.534S 04.034.634S 04.034.734S285 04.034.537S 04.034.637S 04.034.737S300 04.034.540S 04.034.640S 04.034.740S315 04.034.543S 04.034.643S 04.034.743S330 04.034.546S 04.034.646S 04.034.746S345 04.034.549S 04.034.649S 04.034.749S360 04.034.552S 04.034.652S 04.034.752S375 04.034.555S 04.034.655S 04.034.755S390 04.034.558S 04.034.658S 04.034.758S405 04.034.561S 04.034.661S 04.034.761S420 04.034.564S 04.034.664S 04.034.764S435 04.034.567S 04.034.667S 04.034.767S


Implants

5.0 mm Titanium Dual Core Locking Screws, with T25StarDrive recess, for IM nails (gold)◊

– Titanium alloy*

– Lengths: 30 mm– 90 mm (5 mm increments)

– Used for proximal locking in the metaphysis (through the 3 most proximal holes)

– Dual core: smaller core (3.4 mm) for better purchase in cancellous bone, larger core (4.3 mm) to withstand load-bearing from the nail

– Fully threaded

– Self-tapping, blunt tip

5.0 mm Titanium Dual Core Locking Screws, with T25StarDrive recess, for IM Nails (gold)

Length (mm) Length (mm)

04.015.520 30 04.015.555 6504.015.525 35 04.015.560 7004.015.530 40 04.015.565 7504.015.535 45 04.015.570 8004.015.540 50 04.015.575 8504.015.545 55 04.015.580 9004.015.550 60

5.0 mm Titanium Dual Core Locking Screws,with T25StarDrive recess, for IM Nails (gold), sterile

Length (mm) Length (mm)

04.015.518S 28 04.015.552S 6204.015.522S 32 04.015.557S 6704.015.527S 37 04.015.562S 7204.015.532S 42 04.015.567S 7704.015.537S 47 04.015.572S 8204.015.542S 52 04.015.577S 8704.015.547S 57

◊ Available nonsterile or sterile-packed. Add “S” to catalog number to order sterile product.* Titanium-6% aluminum-7% niobium alloy

Synthes 57

Length (mm)

04.005.408 1804.005.410 2004.005.412 2204.005.414 2404.005.416 2604.005.418 2804.005.420 3004.005.422 3204.005.424 3404.005.426 3604.005.428 3804.005.430 4004.005.432 4204.005.434 4404.005.436 4604.005.438 48

Length (mm)

04.005.440 5004.005.442 5204.005.444 5404.005.446 5604.005.448 5804.005.450 6004.005.452 6204.005.454 6404.005.456 6604.005.458 6804.005.460 7004.005.462 7204.005.464 7404.005.466 7604.005.468 7804.005.470 80


4.0 mm Titanium Locking Screws◊, with T25 StarDriverecess, for IM nails (blue)– Titanium alloy*

– Lengths: 18 mm–80 mm (2 mm increments)

– 3.3 mm core diameter

– Fully threaded



Implants

5.0 mm Titanium Locking Screws◊, with T25 StarDriverecess, for IM nails (light green)– Titanium alloy*

– Lengths: 26 mm–80 mm (2 mm increments)85 mm–100 mm (5 mm increments)

– 4.3 mm core diameter

– Fully threaded


Length (mm)

04.005.516 2604.005.518 2804.005.520 3004.005.522 3204.005.524 3404.005.526 3604.005.528 3804.005.530 4004.005.532 4204.005.534 4404.005.536 4604.005.538 4804.005.540 5004.005.542 5204.005.544 5404.005.546 56

Length (mm)

04.005.548 5804.005.550 6004.005.552 6204.005.554 6404.005.556 6604.005.558 6804.005.560 7004.005.562 7204.005.564 7404.005.566 7604.005.568 7804.005.570 8004.005.575 8504.005.580 9004.005.585 9504.005.590 100


Synthes 59

Titanium Angular Stable Locking Screws, with T25 StarDrive recess, for intramedullary nails, sterile*– Titanium alloy**

– Available lengths– 4.0 mm ASLS screw: 26 mm–80 mm– 5.0 mm ASLS screw: 30 mm–100 mm

– Fully threaded shaft with 3 diameters– D1: Provides purchase in reamed near cortex– D2: Expands sleeve, providing angular stability– D3: Holds unexpanded sleeve for screw insertion,

provides purchase in far cortex

– T25 StarDrive recess

– Sterile packaged

D1

D2

D3

* Also available** Titanium-6% aluminum-7% niobium alloy

01.025.008 4.0 mm Angular Stable Locking SystemScrew Set

4.0 mm Titanium Angular Stable Locking Screws, with T25StarDrive recess, for intramedullary nails, sterile, 2 ea.

Length (mm) Length (mm)04.025.416S 26 04.025.444S 5404.025.418S 28 04.025.446S 5604.025.420S 30 04.025.448S 5804.025.422S 32 04.025.450S 6004.025.424S 34 04.025.452S 6204.025.426S 36 04.025.454S 6404.025.428S 38 04.025.456S 6604.025.430S 40 04.025.458S 6804.025.432S 42 04.025.460S 7004.025.434S 44 04.025.462S 7204.025.436S 46 04.025.464S 7404.025.438S 48 04.025.466S 7604.025.440S 50 04.025.468S 7804.025.442S 52 04.025.470S 80



Length (mm) Length (mm)04.025.520S 30 04.025.550S 6004.025.522S 32 04.025.552S 6204.025.524S 34 04.025.554S 6404.025.526S 36 04.025.556S 6604.025.528S 38 04.025.558S 6804.025.530S 40 04.025.560S 7004.025.532S 42 04.025.562S 7204.025.534S 44 04.025.564S 7404.025.536S 46 04.025.566S 7604.025.538S 48 04.025.568S 7804.025.540S 50 04.025.570S 8004.025.542S 52 04.025.575S 8504.025.544S 54 04.025.580S 9004.025.546S 56 04.025.585S 9504.025.548S 58 04.025.590S 100


ASLS Sleeves*

Resorbable Sleeves for Angular Stable Locking Screws,sterile*– 70:30 poly (L /DL-lactide)

– Bioresorbable polymer material gradually resorbs within 18–24 months1

– Inner thread for secure fit to ASLS screw

– Expands in nail’s locking hole to provide angular stability

– 4.0 mm and 5.0 mm sleeves used with corresponding ASLS screws

– Sterile packaged (2 per package)

Resorbable Sleeve for Angular Stable Locking Screws, sterile, 2/pkg.

08.025.032S for 4.0 mm ASLS Screws08.025.044S for 5.0 mm ASLS Screws

ASLS Compatibility with Existing NailsThe Angular Stable Locking System is compatible with all Synthes titanium cannulated nailing systems.

Angular Stable Locking Systems

Nail 4.0 mm 5.0 mmNailing System Diameters (mm) (brown) (light blue)

Tibia Titanium Cannulated Tibial Nail-EX 8, 9 •and Tibial Nail-EX with Proximal Bend 10–13 •

Titanium Tibial Nail (cannulated) 10–13 •

Implants

1 Based on in-vivo animal testing. In-vivo animal testing may not necessarily beindicative of human clinical performance.

* Must be ordered separately.

Synthes 61

Titanium End Caps◊, with T40 StarDrive recess, for Titanium Tibial Nails–EX– Titanium alloy*

– Protect nail threads from tissue ingrowth

– Cannulated

– T40 StarDrive recess

0 mm– Sits flush with end of nail

5 mm, 10 mm and 15 mm extensions– Extend nail height if nail is overinserted

Titanium End Caps◊, with T40 StarDrive recess, for Titanium Tibial Nails–EX (gold)– Securely lock the proximal oblique dual core locking screw

Extension (mm) 04.004.000 0 04.004.001 5 04.004.002 10 04.004.003 15

Titanium End Caps◊, with T40 StarDrive recess, for Titanium Tibial Nails–EX (gray)– Lead-in design for easier end cap insertion

– Will block the two most proximal oblique locking holes

Extension (mm)04.004.008 0 04.004.009 5 04.004.010 10 04.004.011 15


5 mm 10 mm 15 mm0 mm

5 mm 10 mm 15 mm0 mm

03.010.436 14.5 mm Protection Sleeve, straight, for 12 mm–13 mm nails


Instruments for Suprapatellar Insertion

03.010.404 Cannulated Connecting Screw forPercutaneous Instruments for Nails–EX

03.010.430 Handle for Protection Sleeves, for suprapatellar

03.010.433 Wire Guide, 2 holes, 12.0 mm/3.2 mm





03.010.439◊ 12.0 mm Cannulated Drill, long, with largequick coupling

03.010.440◊ Insertion Handle, for suprapatellar


03.010.442 12.0 mm/8.0 mm Protection Sleeve withFlats, for suprapatellar.

Synthes 63

03.010.443 Compression Device, for suprapatellar



Instruments for Suprapatellar Insertion



03.010.446 Extraction Screw, M8, for suprapatellar


03.010.455 12.0 mm Trocar, PEEK for suprapatellar



Instruments for Tibial Nail–EX

Synthes 65

03.010.015 Compression Device, for Titanium CannulatedTibial Nails–EX

03.010.021 Radiographic Ruler, for Titanium CannulatedTibial Nails

03.010.023 Radiographic Canal Width Estimator, for IM nails

03.010.035 12.0 mm Protection Sleeve

03.010.036◊ 12.0 mm Cannulated Drill Bit, large quickcoupling, 190 mm

03.010.024 Holding Device, for guide wires and reaming rods



03.010.052 Aiming Arm, for Titanium Cannulated Tibial Nails–EX

03.010.045 Standard Insertion Handle

03.010.047 Driving Cap with Handle Adapter


03.010.040 12.0 mm Cannulated Awl

03.010.044 Cannulated Connecting Screw, for Standard Insertion Handle


Synthes 67

03.010.060 3.2 mm Three-Fluted Drill Bit, quick coupling,330 mm, 100 mm calibration

03.010.061 4.2 mm Three-Fluted Drill Bit, quick coupling,330 mm, 100 mm calibration

03.010.063 12.0 mm/8.0 mm Protection Sleeve, 188 mm

03.010.064 8.0 mm/3.2 mm Drill Sleeve, 200 mm


03.010.069 3.2 mm Trocar, 210 mm

03.010.070 4.2 mm Trocar, 210 mm

03.010.072 Depth Gauge, for Locking Screws to 100 mm,for IM Nails






03.010.106 Direct Measuring Device, for locking screws to 100 mm, for IM nails


03.010.110 Cannulated StarDrive Screwdriver, T40, self-retaining


Synthes 69

321.17 4.5 mm Pin Wrench, 120 mm


357.22 Hammer Guide, for slide hammer

357.133 Extraction Screw, for Titanium Femoral andTibial Nails

357.398 Cannulated Shaft with 8 mm hex, 125 mm

357.399 3.2 mm Guide Wire, 400 mm


Graphic Case60.010.401 Suprapatellar Instrument Set Graphic Case

Instruments03.010.404 Cannulated Connecting Screw for

Percutaneous Instruments for Nail–EX

03.010.430 Handle for Protection Sleeves, forsuprapatellar





03.010.437S 12.0 mm Outer Protection Sleeve, forsuprapatellar, sterile

03.010.438S 14.5 mm Outer Protection Sleeve, forsuprapatellar, sterile

03.010.439◊ 12.0 mm Cannulated Drill, long, with largequick coupling

03.010.440 Insertion Handle, for suprapatellar


03.010.442 12.0 mm/8.0 mm Protection Sleeve withFlats, for suprapatellar

03.010.443 Compression Device, for suprapatellar



03.010.446 Extraction Screw, M8, for suprapatellar






Suprapatellar Insertion Instrument Set (01.004.305)


Note: For additional information, please refer to package insert. For detailed cleaning and sterilization instructions, please refer to http://www.synthes.com/Cleaning-sterilizationor to the below listed inserts, which will be included in the shipping container: – Processing Synthes Reusable Medical Devices - Instruments, Instrument Trays

and Graphic Cases—DJ1305 – Processing Non-sterile Synthes Implants—DJ1304

Tibial Nail– EX Instrument Set (01.004.303)

Synthes 71

Graphic Case69.004.300 Tibial Nail–EX Instrument Set Graphic Case

Instruments03.010.015 Compression Device, for Titanium

Cannulated Tibial Nails–EX

03.010.021 Radiographic Ruler, for Titanium CannulatedTibial Nails

03.010.023 Radiographic Canal Width Estimator, for IM Nails

03.010.024 Holding Device, for Guide Wires and ReamingRods

03.010.035 12.0 mm Protection Sleeve

03.010.036◊ 12.0 mm Cannulated Drill Bit, large quickcoupling, 190 mm

03.010.040 12.0 mm Cannulated Awl

03.010.044 Cannulated Connecting Screw, for standardinsertion handle, 2 ea.

03.010.045 Standard Insertion Handle

03.010.047 Driving Cap with Handle Adapter

03.010.052 Aiming Arm, for Titanium Cannulated TibialNails–EX


03.010.060◊ 3.2 mm Three-Fluted Drill Bit, quick coupling,330 mm, 100 mm calibration, 2 ea.

03.010.061◊ 4.2 mm Three-Fluted Drill Bit, quick coupling,330 mm, 100 mm calibration, 2 ea.

03.010.063 12.0 mm/8.0 mm Protection Sleeve, 188 mm



03.010.069 3.2 mm Trocar, 210 mm

03.010.070 4.2 mm Trocar, 210 mm

03.010.072 Depth Gauge, for locking screws to 100 mm,for IM nails





Tibial Nail–EX Instrument Set (01.004.303)

03.010.103◊ 3.2 mm Three-Fluted Drill Bit, quick coupling,145 mm, 2 ea.

03.010.104◊ 4.2 mm Three-Fluted Drill Bit, quick coupling,145 mm, 2 ea.

03.010.106 Direct Measuring Device, for Locking Screws to 100 mm, for IM nails


03.010.110 Cannulated StarDrive Screwdriver, T40, self-retaining

03.010.112 Holding Sleeve, with Locking Device

321.17 4.5 mm Pin Wrench, 120 mm, 2 ea.


357.133 Extraction Screw, for Titanium Femoral and Tibial Nails

357.22 Hammer Guide, for Slide Hammer

357.398 Cannulated Shaft with 8 mm hex, 125 mm

357.399 3.2 mm Guide Wire, 400 mm, 3 ea.


Synthes 73

Tibial Nail– EX Implant Set (01.004.304)

Graphic Case690.504 Locking Screw Rack, for Tibial Nail–EX Implants

Instrument319.97 Screw Forceps

ImplantsTitanium End Caps, with T40 StarDrive recess, for Tibial Nails–EX◊ (gold)

Extension (mm)04.004.000 0 04.004.001 5 04.004.002 1004.004.003 15

Titanium End Caps, with T40 StarDrive recess, extended tip,for Tibial Nails–EX◊ (gray), 2 ea.

Extension (mm)04.004.008 0 04.004.009 5 04.004.010 1004.004.011 15


Length (mm) 04.015.520 30 04.015.525 35 04.015.530 40 04.015.535 45 04.015.540 50 04.015.545 55 04.015.550 60

Length (mm) 04.015.555 65 04.015.560 70 04.015.565 75 04.015.570 80 04.015.575 85 04.015.580 90

5.0 mm Titanium Dual Core Locking Screws, with T25 StarDrive recess, for IM nails◊, 2 ea.


Tibial Nail–EX Implant Set (01.004.304)


5.0 mm Titanium Locking Screws, with T25 StarDrive recess,for IM Nails◊, 2 ea.

Length (mm) 04.005.544 5404.005.546 5604.005.548 5804.005.550 6004.005.552 6204.005.554 6404.005.556 6604.005.558 6804.005.560 7004.005.562 7204.005.564 7404.005.566 7604.005.568 7804.005.570 80

Length (mm) 04.005.516 2604.005.518 2804.005.520 3004.005.522 3204.005.524 3404.005.526 3604.005.528 3804.005.530 4004.005.532 4204.005.534 4404.005.536 4604.005.538 4804.005.540 5004.005.542 52

4.0 mm Titanium Locking Screws, with T25 StarDrive recess,for IM Nails◊, 2 ea.

Length (mm) 04.005.416 2604.005.418 2804.005.420 3004.005.422 3204.005.424 3404.005.426 3604.005.428 3804.005.430 4004.005.432 4204.005.434 4404.005.436 4604.005.438 4804.005.440 5004.005.442 52

Length (mm) 04.005.444 5404.005.446 5604.005.448 5804.005.450 6004.005.452 6204.005.454 6404.005.456 6604.005.458 6804.005.460 7004.005.462 7204.005.464 7404.005.466 7604.005.468 7804.005.470 80

Synthes 75

Tibial Nail–EX Instrument and Titanium Implant Set (01.004.300)

01.004.300 consists of:01.004.303 Tibial Nail–EX Instrument Set

01.004.304 Tibial Nail–EX Implant Set




Length Length(mm) (mm)

04.025.416S 26 04.025.444S 5404.025.418S 28 04.025.446S 5604.025.420S 30 04.025.448S 5804.025.422S 32 04.025.450S 6004.025.424S 34 04.025.452S 6204.025.426S 36 04.025.454S 6404.025.428S 38 04.025.456S 6604.025.430S 40 04.025.458S 6804.025.432S 42 04.025.460S 7004.025.434S 44 04.025.462S 7204.025.436S 46 04.025.464S 7404.025.438S 48 04.025.466S 7604.025.440S 50 04.025.468S 7804.025.442S 52 04.025.470S 80



Length Length(mm) (mm)

04.025.520S 30 04.025.550S 6004.025.522S 32 04.025.552S 6204.025.524S 34 04.025.554S 6404.025.526S 36 04.025.556S 6604.025.528S 38 04.025.558S 6804.025.530S 40 04.025.560S 7004.025.532S 42 04.025.562S 7204.025.534S 44 04.025.564S 7404.025.536S 46 04.025.566S 7604.025.538S 48 04.025.568S 7804.025.540S 50 04.025.570S 8004.025.542S 52 04.025.575S 8504.025.544S 54 04.025.580S 9004.025.546S 56 04.025.585S 9504.025.548S 58 04.025.590S 100

ASLS Screw Sets

Alternative Set Configurations

01.025.001 Angular Stable Locking System Screw Set Consists of:4.0 mm ASLS Screw Set (01.025.008) and 5.0 mm ASLS Screw Set (01.025.009)

ASLS Sleeves*

Resorbable Sleeve for Angular Stable Locking Screws, sterile, 2/pkg.

08.025.032S for 4.0 mm ASLS Screws08.025.044S for 5.0 mm ASLS Screws

* Must be ordered separately.

Synthes 77

Also Available

Set 01.004.306 Flexible Reamer Set, Long, for IM nails

150.060 Flexible Reamer Set for IM nails

Instruments03.010.017 Tibial Nail–EX Insertion Handle

03.010.046 Percutaneous Insertion Handle

03.010.100◊ 3.2 mm Three-Fluted Drill Bit, quick coupling,145 mm, for Radiolucent Drive

03.010.101◊ 4.2 mm Three-Fluted Drill Bit, quick coupling,145 mm, for Radiolucent Drive

03.010.119 4.6 mm Cleaning Brush

03.010.120 4.6 mm Cleaning Stylet

03.010.121 Large Hexagonal Screwdriver, 3.5 mm widthacross flats

03.010.136 Short Compression Device, for Titanium Cannulated Tibial Nail–EX

03.010.137 Long Compression Device, for Titanium Cannulated Tibial Nail–EX

03.010.145 Cannulated Connecting Screw, with internalthread for short insertion handle

03.010.146 Cannulated Connecting Screw, forpercutaneous insertion handle

314.119 StarDrive Screwdriver Shaft, T25, self-retaining, quick coupling, 165 mm

351.706S 2.5 mm Reaming Rod with ball tip, 950 mm,sterile

351.707S 2.5 mm Reaming Rod with ball tip and extension, 950 mm, sterile

357.408 Cleaning Stylet (3.2 mm)

357.409 Cleaning Brush (3.2 mm)

360.251 7.5 mm Intramedullary Reduction Tool, 460 mm

393.105 Small Universal Chuck with T-Handle

394.35 Large Distractor, complete

399.43 Hammer, 700 grams


Implants5.0 mm Titanium Dual Core Locking Screws, with T25 StarDrive recess, for IM nails, sterile only

Length (mm)

04.015.518S 28

04.015.522S 32

04.015.527S 37

04.015.532S 42

04.015.537S 47

04.015.542S 52

04.015.547S 57

04.015.552S 62

04.015.557S 67

04.015.562S 72

04.015.567S 77

04.015.572S 82

04.015.577S 87

Power Equipment511.30 Radiolucent Drive

511.73 Jacobs Chuck with Key (large)

511.75 Quick Coupling, for drill bits

511.761 Large Quick Coupling

511.785 Reduction Drive Unit

511.791 Quick Coupling for Kirschner wires

530.100 Power Drive

530.200 Battery, for Power Drive

530.280 Battery Casing, for Power Drive

Synthes USA1302 Wrights Lane EastWest Chester, PA 19380Telephone: (610) 719-5000To order: (800) 523-0322Fax: (610) 251-9056

Synthes (Canada) Ltd.2566 Meadowpine BoulevardMississauga, Ontario L5N 6P9Telephone: (905) 567-0440To order: (800) 668-1119Fax: (905) 567-3185

© 2011 Synthes, Inc. or its affiliates. All rights reserved. Synthes, Expert Nail and Expert Nailing System are trademarks of Synthes, Inc. or its affiliates. Printed in U.S.A. 5/12 J10459-B

www.synthes.com

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