Modular Sternal Cable System (PDF)synthes.vo.llnwd.net/o16/Mobile/Synthes North America... · 2011....

Modular Sternal Cable System.Flexibility and strength in sternalclosure and repair.

Technique Guide

Introduction

Surgical Technique

Product Information

Table of Contents

Modular Sternal Cable System 2

Indications 4

Modular Sternal Closure Options 4

Preoperative Considerations 5

Peristernal Technique 6

Transsternal Technique 9

Using Cable, Cannulated Screws and Plates 15

Sternal Reduction 21

Securing Cables 22

Emergency Cable Removal 27

Postoperative Considerations 27

Implants 28

Instruments 30

Set Lists 32

Synthes—In the Service of Health 37

Synthes CMF

Modular Sternal Cable System

The Synthes Modular Sternal Cable System is a set of stainless steel implants* and instruments designed to facilitate sternal repair and reconstruction. This system addresses the unique requirements of sternal closures.

The sternal cable can be placed around the bone, throughcannulated screws, and/or through plates. The cable’s flexibility and strength enable multiple closure options that provide stable fixation.

The system’s modular design provides flexibility for placementof implants depending on the patient’s anatomy and boneintegrity. Implants can be combined to meet a specific patient need.

The Tensioner/Crimper/Cutter is a single, multipurpose instrument used to tension the cable, crimp the ferrule, and cut the cable.

* Implant quality 316L stainless steel

2 Synthes CMF Modular Sternal Cable System

* Synthes Mechanical Test Number MT04-455

1.0 mm Sternal Cable– Flexible cable contours to the shape of the sternum

– 1.0 mm diameter provides greater bone-to-implant contact area than wire

– Multifilament structure provides improved strength and flexibility compared to wire*

– Cable end is very soft when cut, increasing handling safety

– Works with various closure techniques

– Ferrules are crimped onto the end of the cable to secure the finished construct

– Low-profile parallel end fitting reduces implant palpability

– Available with or without a quick-release needle

Synthes CMF 3

Ferrule Parallel End Fitting

4.5 mm Sternal Reconstruction Plates– Used to reconstruct hemisterna, especially in cases

with transverse fractures

– Distribute forces along the length of the sternum, reducing the likelihood of bony failure

– Attach to the sternum with cannulated screws

– Contourable, to closely match the sternum

– Available in several lengths (80 mm–192 mm) to minimize intraoperative plate cutting

4.5 mm Sternal Cannulated Screws– Easily insert into the manubrium or sternal body using

the adjustable screwdriver blade with spade point

– Eliminate the need to insert a needle through the sternum

– Cannulation provides a metal surface for cable to passthrough for reinforcement in weak cancellous bone

– Blunt tip allows safe bicortical insertion

– Available in lengths from 8 mm to 28 mm, in 1 mm increments

Indications and Modular Sternal Closure Options


Indications– Sternal repair and reconstruction

Modular Sternal Closure Options– Flexibility in sternal closure due to modular options

– Intraoperative choice depending on patient’s needs

– Stable fixation in all configurations

– Sternal cable with an improved strength and stability compared to wire*

– Sternal cannulated screws for reinforcement of sternal bone quality

– Sternal reconstruction plates for repair of transverse fractures

Peristernal using cable with needle Sternal reconstruction using cable, cannulated screws and plates

Transsternal using cable and cannulatedscrews

* Synthes Mechanical Test Numbers: MT03-055, MT03-006, MT03-007, MT04-455, SET_20060413 and SET_20060213

Preoperative Considerations

Preoperative considerationsThe 1.0 mm sternal cable is designed to be used alone(with needle) or with cannulated screws and plates (withoutneedle). The benefits of each technique, the needs of the patient, and surgeon preference should be considered whenselecting a method of closure. The method chosen will dictate the sternal cable sets that should be prepared for the surgical procedure.

This guide outlines three surgical techniques for using cableto close the sternum:– Peristernal (around the sternum) using cable with needle

– Transsternal (through the sternum) using cable and cannulated screws

– Sternal reconstruction using cable, cannulated screws, and plates

Synthes CMF 5

Peristernal Technique Using Cable with Needle


1Suture cable around sternum

Suture the cable around the two halves of the sternum, using the attached cutting needle. The needle can be sutured through the manubrium and the intercostal spaces.

2Remove quick-release needle

After weaving the cable, remove the quick-release needlefrom the end of the cable by holding the cable with onehand and pulling sharply on the needle with forceps.

Remove the silicone tip guard from the parallel end fitting.Pass the end of the cable through the parallel end fitting.

Important: After passing the end of the cable through theparallel end fitting, the cable ends should be on oppositesides of the parallel end fitting.

Synthes CMF 7

Peristernal Technique Using Cable with Needle continued

4 Place additional cables

Continue with placement of additional cables as needed for the desired closure.

A minimum of three cables placed in a figure of eight should be used for proper fixation.

Proceed to page 21 for reducing the sternum and securing the cables.


1Identify screw locations

Instrument

03.501.001 Depth Gauge, for 4.5 mm Sternal Cannulated Screws

Using a marking pen, identify locations for screw placementin the manubrium and sternal body.

Using the depth gauge, measure the thickness of the sternum medial to the planned screw location.

Select the appropriate length screw based on the depthgauge reading. If attaching a plate to the sternum with the screw, add 3 mm to the screw length.

Transsternal Technique Using Cable (without Needle) and Cannulated Screws

Bicortical screw insertion is critical for maximum effectiveness. Careful measurement and screw selection is necessary.

Synthes CMF 9

Transsternal Technique Using Cable (without Needle) and Cannulated Screws continued

2 Assemble screwdriver

Instruments

311.006 Screwdriver Handle with hex coupling

351.034 4.5 mm Hexagonal Adjustable ScrewdriverBlade with spade point

Insert the 4.5 mm hexagonal adjustable screwdriver bladewith spade point into the screwdriver handle. Turn the adjustable sleeve on the screwdriver blade until the screwlength determined in Step 1 is indicated. Insert the tip of the screwdriver into the recess of the screw and press downto secure the screw to the blade.

Important: The tip of the blade should protrude approximately 2 mm beyond the tip of the screw.


3Pierce outer cortex of sternum

Instruments


351.026 2.7 mm Awl

In dense cortical bone, use the 2.7 mm awl with the screwdriver handle to pierce the outer cortex of the sternumin the desired screw location.

The awl can also be used through a plate if necessary.

Synthes CMF 11


4Insert screws

Insert the screw into the sternum.

When the screw is properly seated, remove the screwdriverblade by pulling straight back. Repeat Steps 2–4 to implantadditional screws.


Proper screw insertion—anterior cortex

Proper screw insertion—bicortical purchase

5Insert cable

Instruments

351.027 Obturator

351.028 Cable Passer

Insert the cable anterior to posterior through the first cannulated screw.

Insert the cable passer with obturator into a screw in the opposite hemisternum. Remove the obturator. Pass the cable through the cable passer from the posterior aspect of the sternum.

Note: The cable passer can also be used to pass the cablethrough the intercostal space.

Synthes CMF 13



6Remove cable passer

After pushing the end of the cable through the top of the cable passer, remove the cable passer while holding onto the cable. Continue by passing the cable through additional screws.

When the cable weaving is complete, pass the end of the cable through the parallel end fitting. Repeat with additionalcables as necessary.

Important: After passing the end of the cable through theparallel end fitting, the cable ends should be on oppositesides of the parallel end fitting.

Proceed to page 21 for reducing the sternum and securingthe cables.

Using Cable, Cannulated Screws and Plates

4.5 mm sternal reconstruction plates can be used to fixatetransverse fractures of the sternum. Plate implantationshould be performed in conjunction with muscle flap advancement to ensure adequate blood supply, and to provide additional soft tissue coverage to the region.

1 Select plate

Instrument

329.40.98 Bending Template

Select the plate of appropriate length.

Using the bending template, determine the contour of the hemisternum.

Synthes CMF 15

Using Cable, Cannulated Screws and Plates continued

2Contour plate

Instrument

329.142 Combination Bending Pliers

With the bending template as a guide, use the combinationbending pliers to contour the plate, in the following sequence:

In-plane bendPlace the plate into the jaws of the bender. Squeeze the handles together to bend the plate.

Out-of-plane bendPlace the plate into the jaws of the bender. Squeeze the handles together to bend the plate.

OR

Place the plate into the “duckbill” end of the bender. Squeeze the handles together to bend the plate.


Place the plate on the sternum to verify contour accuracy.

Profile of plate on sternum

Synthes CMF 17


3Attach plate to sternum

Instruments

03.501.001 Depth Gauge, for 4.5 mm Sternal Cannulated Screws


351.026 2.7 mm Awl

351.034 4.5 mm Hexagonal Adjustable ScrewdriverBlade

Using 4.5 mm sternal cannulated screws, attach the plate to the sternum as outlined in Steps 2–4 of the transsternaltechnique on pages 10–12. Placing screws every two to three plate holes is recommended. If spanning a transverse fracture, placing screws adjacent to (but not in) the fractureis also recommended.

Repeat this process with the other hemisternum as needed.


4Weave the cable

Weave the cable through the cannulated screws as described in Steps 5–6 of the transsternal technique on pages 13–14.

Note: It is recommended that a minimum of ten loops beused for closure with plates and screws, either using tensingle loops, or five figure-of-eight loops (two loops each),or a combination of each totalling ten loops.

Alternative TechniqueAlternatively, the cable may be used without the parallel endfitting and terminated with a ferrule after passing it through a side hole in the plate. To use this technique, first remove the parallel end fitting from the cable. Pass the cable throughthe first cannulated screw from anterior to posterior. Thefinished end of the cable will sit flush in the head of thescrew, as shown. (Figure 1)

Synthes CMF 19

Finished endof cable

Side hole in plate

Figure 1


4Weave the cable continued

When finished weaving the cable, pass it through a side hole in the plate.

Proceed to page 21 for reducing the sternum and securingthe cables.


Sternal Reduction

1Reduce sternum

Instruments

351.026 2.7 mm Awl

398.902* Sternal Reduction Forceps

398.903 Sternal Reduction Forceps, angled, with teeth

398.985 Bone Reduction Forceps

To achieve anatomical reduction of the sternum, the use of reduction forceps to approximate the sternal halves is recommended.

The tips of the reduction forceps can be placed intercostallyor, if necessary, the 2.7 mm awl can be used to create pilotholes in the body of the sternum.

2Align sternal halves

After the forceps are placed, tighten them to align the sternal halves into the correct anatomic position.

Important: The tips of the forceps should not be placedagainst the plates, screws or cables during reduction.

Synthes CMF 21

* Also available

Securing Cables


1Insert ferrule into instrument

Instrument

391.291 Tensioner/Crimper/Cutter

Tighten all cables by hand.

Pulling back on the gold collar of the tensioner/crimper/cutter, place the ferrule into the flat side of the nose of the instrument.

Release the gold collar to secure the ferrule in the nose of the instrument.

Note: Handles must be completely open when placing the ferrule in the nose or it will not fit.

Synthes CMF 23

2Pass cable through ferrule

Pass the cable through the flat side of the nose first.

Note: The gold collar may need to be pulled back slightly topass the cable through the ferrule. Make sure the ferrule isfacing up before pulling back on the collar, to ensure that itdoes not fall out of the instrument.

3Wrap cable into tensioning wheel

Wrap the cable clockwise (in the direction of the arrow) and pull forward until one or two audible clicks are heard.

Note: The gold collar can be used to rotate the nose of the tool.

Securing Cables continued

4Tension cable

Ensure tensioning wheel is set.

Turn the wheel counterclockwise until the ball detent is engaged, if it is not already engaged.

Ensure the parallel end fitting and ferrule are positionedstraight and along the line of the cable.

Important: The nose of the instrument should be square to the cable.

Turn the wheel clockwise (in the direction of the arrow) totension the cable appropriately. The cable should fit snuglyto the bone.

Important: This instrument has a clutch mechanism whichwill slip when the maximum tension is achieved, preventingovertensioning of the cable.

Note: Maximum tension is ensured when two audible clicksare heard. Avoid angling the ferrule during tensioning, asthis may cut the cable prematurely.


Not engaged (incorrect)Engaged (correct)

Ball detent

5Crimp and cut cable

When correct position and tension have been achieved,squeeze the handles together completely to crimp and cut the cable.

Important: Not squeezing the handles together completelywill result in an incomplete crimp. The handles must be fullysqueezed together to complete the crimping and cutting sequence.

Synthes CMF 25

Securing Cables continued

6Remove instrument from crimped ferrule

Pull back on the gold collar and remove the instrument fromthe crimped ferrule.

Verify visually that the cable is tight and that the sternalhalves are correctly approximated.


Emergency Cable Removal and Postoperative Considerations

Emergency cable removal

Instrument

391.905 Cable Cutter

In case of emergency, the cable can be cut using standard wire cutters; however, using the cable cutter is recommended.

If cannulated screws have been used, they may be left in the sternum and used again as a channel for cable passage.

Postoperative considerations

Standard sternal precautions are recommended for a minimum of six weeks after surgery including:

– Do not lift more than ten pounds

– Do not pull or lift the patient by the arms

– Do not raise arms greater than 90° at shoulder level

– Avoid trunk twisting

– For strong cough, press pillow to chest

Synthes CMF 27

Implants

1.0 mm Sternal Cable, with long crimping ferrule and parallel end fitting, sterile

– Available with or without needle

– 1.0 mm diameter

– Multifilament

– Implant quality 316L stainless steel

Cables (without needle)

291.911.01S (1/pkg.)291.911.03S (3/pkg.)

Cables with needle

291.916.01S (1/pkg.)291.916.03S (3/pkg.)

1.0 mm Sternal Crimping Ferrule

291.906 (5/pkg.)

1.0 mm Sternal Parallel End Fitting

291.907 (5/pkg.)


Ferrule Parallel End Fitting

Cable with needle

Cable (without needle)

Synthes CMF 29

4.5 mm Sternal Reconstruction PlatesLengths: 80 mm–192 mm (16 mm increments)

4.5 mm Sternal Cannulated ScrewsLengths: 8 mm–28 mm (1 mm increments)

Length (mm) 213.508 8213.509 9213.510 10213.511 11213.512 12213.513 13213.514 14213.515 15213.516 16213.517 17213.518 18

Length (mm) 213.519 19213.520 20213.521 21213.522 22213.523 23213.524 24213.525 25213.526 26213.527 27213.528 28

Length (mm) Holes260.060 80 10260.062 96 12260.064 112 14260.066 128 16260.068 144 18260.070 160 20260.072 176 22260.074 192 24

Instruments

03.501.001 Depth Gauge, for 4.5 mm Sternal CannulatedScrews

311.006 Screwdriver Handle

329.40.98 Bending Template

329.142 Combination Bending Pliers

351.026 2.7 mm Awl

351.027 Obturator

351.028 Cable Passer


351.034 4.5 mm Hexagonal Adjustable ScrewdriverBlade with Spade Point

351.035 Replacement Blade, for 4.5 mm HexagonalAdjustable Screwdriver Blade (351.034)

391.905 Cable Cutter

398.903 Sternal Reduction Forceps, angled, with teeth

398.985 Reduction Forceps

Synthes CMF 31

391.291 Tensioner/Crimper/Cutter

Modular Sternal Cable SystemCable Instrument Set (01.501.602)

Graphic Case 690.695 Graphic Case, for Modular Sternal Cable

System Cable Instrument Set

Instruments391.291 Tensioner/Crimper/Cutter, for 1.0 mm

Sternal Cable, 2 ea.

391.905 Cable Cutter, standard

398.903 Sternal Reduction Forceps, angled, with teeth, 2 ea.

398.985 Bone Reduction Forceps, large, 2 ea.

Implants291.906 1.0 mm Sternal Crimping Ferrule, long,

1 pkg. of 5

291.907 1.0 mm Sternal Parallel End Fitting, 1 pkg. of 5


Note: For additional information, please refer to package insert.

Modular Sternal Cable System4.5 mm Cannulated Screw and Plate Set (01.501.610)

Synthes CMF 33

Graphic Cases, Modules and Screw Length Markers690.696 Modular Sternal Cable System, 4.5 mm

Cannulated Screw and Plate Set GraphicCase

305.696 Screw Module, for 4.5 mm Sternal Cannulated Screws

305.697 Plate Module, for 4.5 mm Sternal Reconstruction Plates

304.108– Screw Length Markers (10/pkg.)304.126 1 pkg. of ea.: 8 mm–26 mm

Instruments03.501.001 Depth Gauge, for 4.5 mm Sternal

Cannulated Screws

311.006 Screwdriver Handle with hex coupling,medium, 2 ea.

329.142 Combination Bending Pliers, for 2.0 mm/2.4 mm plates

329.40.98 Bending Template, 37 holes, for reconstruction plates, 2 ea.

351.026 2.7 mm Awl, hex coupling

351.027 Obturator, for Sternal Cable Passer, 37 mm

351.028 Cable Passer, for 1.0 mm Sternal Cable

351.034 4.5 mm Hexagonal Adjustable ScrewdriverBlade, with spade point, hex coupling, 2 ea.

Implants4.5 mm Sternal Cannulated Screws

213.508– 10 ea.: 8 mm, 9 mm, 25 mm and 26 mm

213.526 15 ea.: 10 mm–24 mm

4.5 mm Sternal Reconstruction Plates, 4 ea.

260.060 10 holes, 80 mm

260.062 12 holes, 96 mm

260.064 14 holes, 112 mm

260.066 16 holes, 128 mm

260.068 18 holes, 144 mm

260.070 20 holes, 160 mm

260.072 22 holes, 176 mm

260.074 24 holes, 192 mm

305.696

305.697

Modular Sternal Cable System4.5 mm Cannulated Screw Set (01.501.601)

Graphic Cases, Modules and Screw Length Markers690.683 Modular Sternal Cable System

Cannulated Screw Set Graphic Case

305.696 Screw Module, for 4.5 mm Sternal Cannulated Screws

304.108– Screw Length Markers, 8 mm–26 mm,304.126 (10/pkg.), 1 pkg. of each

Instruments03.501.001 Depth Gauge for 4.5 mm Sternal

Cannulated Screws

311.006 Screwdriver Handle with hex coupling, medium, 2 ea.




351.034 4.5 mm Hexagonal Adjustable Screwdriver Blade, with spade point, hex coupling, 2 ea.


213.508– 10 ea.: 8 mm, 9 mm, 25 mm and 26 mm

213.526 15 ea.: 10 mm–24 mm


Synthes CMF 35

Modular Sternal Cable System Compact 4.5 mm Cannulated Screw and Plate Set (01.501.611)

Graphic Case, Module and Screw Length Markers690.688 Graphic Case for Compact 4.5 mm

Cannulated Screw and Plate Set

305.698 Compact 4.5 mm Cannulated Screw and Plate Module

304.108– Screw Length Markers, 8 mm–26 mm,304.126 (10/pkg.), 1 pkg. of each

Instruments03.501.001 Depth Gauge, for 4.5 mm Sternal

Cannulated Screws

311.006 Screwdriver Handle with hex coupling, medium

311.023 Ratcheting Screwdriver Handle, 2 ea.

329.142 Combination Bending Pliers, for 2.0 mm/2.4 mm plates

329.40.98 Bending Template, 37 holes, for reconstruction plates, 2 ea.




351.034 4.5 mm Hexagonal Adjustable Screwdriver Blade, with spade point, hex coupling, 2 ea.


213.508– 5 ea.: 8 mm, 9 mm, 10 mm, 11 mm and 26 mm213.526 10 ea.: 12 mm–25 mm

4.5 mm Sternal Reconstruction Plates, 2 ea.

260.060 10 holes, 80 mm

260.062 12 holes, 96 mm

260.064 14 holes, 112 mm

260.066 16 holes, 128 mm

260.068 18 holes, 144 mm

260.070 20 holes, 160 mm

260.072 22 holes, 176 mm

260.074 24 holes, 192 mm


213.525– 4.5 mm Sternal Cannulated Screws,

213.528 25 mm–28 mm

Label Clips, for sternal plates

260.060LC for plate 260.060

260.062LC for plate 260.062

260.064LC for plate 260.064

260.066LC for plate 260.066

260.068LC for plate 260.068

260.070LC for plate 260.070

260.072LC for plate 260.072

260.074LC for plate 260.074

305.698LC for Sternal Module 305.698

305.001LC blank

1.0 mm Sternal Cables, with long crimping ferrule and parallel end fitting, sterile

291.911.01S (without needle), 1 per pkg.

291.911.03S (without needle), 3 per pkg.

291.916.01S with needle, 1 per pkg.

291.916.03S with needle, 3 per pkg.

304.125– Screw Length Markers, 304.128 25 mm–28 mm

351.035 Replacement Blade, for 4.5 mm HexagonalAdjustable Screwdriver (351.034)

398.902 Sternal Reduction Forceps

Also Available

Synthes—In the Service of Health

Synthes is an internationally leadingcompany in medical technology.

Over 8,400 Synthes employees worldwideare involved in serving the needs of surgeons,surgical support staff and patients. Synthes—a company specializing in the field of osteosynthesis—develops, producesand markets surgical instruments, implants,and biomaterials for the surgical treatmentof bone fractures and reconstructions of the human skeleton and its associated soft tissue.

The main goal of Synthes is to provide safeand highly advanced implants, surgical instruments and technologies that enable reliable operations, fast healing and a complaint-free life after surgery. We gua rantee high quality, continuous innovationand a focused customer orientation.

AO—A medically oriented nonprofit organization in the service of surgeonsand patients

Synthes works closely with the AO Foundation, and is licensee of the productsbearing the brand name Synthes.

AO stands for “Arbeitsgemeinschaft für Osteosynthesefragen” (Association for theStudy of Internal Fixation). The foundationboasts more than 5,000 surgeons who participate in AO activities throughout theworld—one of the largest networks in thefield of medicine. In the professional world,this surgeon-led, scientific nonprofit organi-zation focused on treating bone fracturesand diseases of the musculoskeletal system is a pioneer in research, documentation and development.

The Technical Commission of the AO monitors the implementation of medicalstudies of new products, as a fully independent institution administered byhealth professionals. Only when it confirmsthe effectiveness and quality of a productdoes it award the seal of quality of the Synthes brand. Surgeons throughout theworld place great trust in Synthes productsbecause they know they have been carefullyevaluated and tested.

Yet even the best implants and instrumentsare useless if they are not used properly.AO International, the arm of the foundationresponsible for training, annually organizesmore than 160 AO courses throughout the world that offer practical exercises and discussions. Since the beginnings of the AO,experienced AO physicians have providedtheoretical and practical training for morethan 500,000 surgeons and more than150,000 surgical support staff members.

Synthes products are a familiar sight in nearly every operating room in the world.

AO Foundation, Davos, Switzerland

Synthes CMF 37

The AO Foundation offers numerous training courses worldwide.

Synthes CMF1302 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

© 2006 Synthes, Inc. or its affiliates. All rights reserved. Synthes is a trademark of Synthes, Inc. or its affiliates. Printed in U.S.A. 7/08 J6041-E

www.synthes.com

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