Hansson Pinloc System - Swemac Resource...

Hansson Pinloc® SystemFor femoral neck fractures

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Hansson Pinloc® SystemFor femoral neck fractures

The Hansson Pinloc System is an evolution of the Hansson Pin System. It has been developed to overcome the problem of fracture displacement after internal fixation and still maintain the same features as the Hansson Pin System.

Until 2011, the Hansson Pin System has been used in more than 250.000 patients with femoral neck fractures or slipped capital femoral epiphysis. The Hansson Pin System was developed based on research concerning the effects of implants on the blood supply to the femoral head, with the objective to reduce the risk of femoral head necrosis.

The problemThe femoral neck fracture is often referred to as the last unsolved fracture. Displacement of the fracture is one of the main complications associated with fixation of femoral neck fractures and occurs in about 5-8% of the undisplaced fractures and up to 20-30% of the displaced fractures.

Traditional fixation implants like cannulated screws or sliding hip screws will often fail to hold a fracture. These implants cannot provide enough mechanical stability to allow the fracture to heal in its reduced position.

European patents

Patent Application No. EP2185089 Pending

Patent Application No. EP2271274 Pending

Patent No. EP1307152

Patent No. EP1492465

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The solutionBy locking three Hansson Pins and a Plate into one dynamic unit, the Hansson Pinloc implant can recreate the stability of an unbroken hip. The Pins can not rotate in relation to each other as often is the case when independent screws are used. This means that the femoral head can only rotate if the bone cuts through all Pins simultaneously.

Our initial results indicate that the Hansson Pinloc System can reduce the occurrence of fracture healing complications and increase the quality of life for the patient.

The principleAfter reduction of the fracture, three cylindrical Hansson Pins are inserted through a locking plate and into pre-drilled holes.

The Hansson Pins are atraumatically advanced into the femoral head. Fixation in the femoral head is achieved by pushing the inner sliding tongue out through the window of the outer Pin.

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Combined Introduction and extraction Screw

Threaded portion of the Pin

Inner sliding tongueOuter pin

Product description

The Hansson Pinloc System consists of Plates, Pins and Pegs in different sizes which can be combined to fit each specific situation. The primary surgical technique for femoral neck fractures utilizes three Pins locked by a Plate.

All implants are made from titanium alloy (Ti6Al4V) and available sterile for immediate use. MRI scans can be undertaken without removal of the implant.

Hansson Pinloc Plates ll When the Pin has been fully seated in the Plate, the hook

will automatically point towards the center of the femoral head. The distance between the anterior and posterior Pins are 4.5, 5.5 and 6.5 mm and between the inferior and the proximal Pins 6.0, 8.0 and 10.0 mm. The angle between the Pins and the Plate is 125° (CCD°).

Hansson Pinsll The Pin consists of three parts, an outer pin, an inner

sliding tongue and an introduction screw. The Pins are available in 5 mm increments, from 70 to 130 mm. The diameter of the Pin is 6.5 mm.

ll A short Anterior Peg can be used instead of the anterior Hansson Pin if the femoral neck is too narrow to allow insertion of three Hansson Pins. The Anterior Peg will stabilize the lateral cortex. The Anterior Peg is 40 mm in length and the diameter of the Peg is 6.5 mm.

4.5 mm

6.0 mm

5.5 mm

8.0 mm

6.5 mm

10.0 mm

Anterior Peg 6.5 mm

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Prevents non-union

Rotationally stable proximal and distal fixation

ll Strong resistance to rotation By locking three Pins and a Plate into one dynamic unit, the Hansson Pinloc implant can recreate the stability of an unbroken hip. The Pins can not twist in relation to each other as often is the case when independent cannulated screws are used. This means that the femoral head can only rotate if all Pins cut through bone simultaneously.

ll Use of cortical bone for buttressing Each Pin contacts strong cortical bone in three places to provide maximum stability. The Hansson Pinloc System does not rely on soft cancellous bone for support and the risk of displacement is thereby minimized.

ll Large contact area It is important to have a large contact area at the fracture site in order to stabilize the fracture. The shaft diameter of the Pin is 6.5 mm. The most common screws used for femoral neck fractures have a shaft diameter of only 4.5-4.8 mm.

ll Firm anchorage The hook of each Pin engages in subchondral bone to provide secure anchorage and prevent migration or backing out.

Uta S, Inoue Y, Kaneko K, Mogami A, Tobe M, Maeda M, Iwase H, Obayashi O.

Treatment of femoral neck fracture with Hansson Pins. A biomechanical study.

Japan Clinical Biomechanics. 2000; (21):377-83.

Two Hansson Pins placed more than 8 mm apart have better rotational resistance than three cannulated screws (ACE-CHS)

Two Hansson Pins have greater fixation strength of the femoral head than three cannulated screws (ACE-CHS)

Three point contact with cortical bone provides maximum stability. Inferior Pin contacts inferior cortex of the femoral neck.

The posterior Pin contacts the posterior cortex of the femoral neck. The anterior Pin contacts the anterior cortex of the femoral neck.

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Prevents non-union

Prevents posterior tiltll The posterior Pin can not slide independent

of the other Pins Post-operatively, the Hansson Pinloc will allow the distal fragment to slide on the parallel Pins, compressing the fracture. By locking three Pins and a Plate together into one dynamic unit, the posterior Pin can not slide independent of the other Pins. This prevents posterior tilt and shortening on the posterior side.

14/25 (0.6) of patients with posterior tilt of ≥ 20° were reoperated, as compared to 12/88 (0.1) of patients with tilt of < 20° (p < 0.001). A posterior tilt of ≥ 20° was the only significant predictor of reoperation.

Palm H, Gosvig K, Krasheninnikoff M, Jacobsen S, Gebuhr P.

A new measurement for posterior tilt predicts reoperation in undisplaced femoral neck fractures: 113 consecutive

patients treated by internal fixation and followed for 1 year. Acta Orthop. 2009 Jun;80(3):303-7.

The Hansson Pinloc has the ability to compress the fracture, maintain length and prevent posterior tilt.

Compression Maintaining length

Pre-operative posterior tilt in undisplaced (Garden I-II) femoral neck fractures is influencing the rate of reoperation.

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Simple instrumentation ensures precise parallel placement.

The parallel placement of the Pins does not depend on thin Guide Wires.

6.7 mm Drills are introduced through deep parallel drill tubes ensuring parallel placement of the Pins.

Parallel placement of the Pins ensure continous compression at the fracture site.

Allows early mobilisationll Strong stable fixation with continuous compression at the

fracture site, allow most patients to be mobilized during their first postoperative day and discharged early.

The positioning of the osteo-synthesis material was significantly (P=0.042) better for the hook-pins

The hook pin was considered easier to use by the surgeons due to more easy handling and better guide instrument

Mjørud J, Skaro O, Solhaug JH, Thorngren KG.

A randomised study in all cervical hip fractures osteosynthesis with Hansson hook-pins versus AO-screws in 199 consecutive

patients followed for two years. Injury. 2006 Aug;37(8):768-77. Epub 2006 Feb 14.

Maintains contact with bonell Precise parallel placement

Precise parallel placement allows for fracture dynamization thus ensuring continuous contact with bone, even during resorption. Reducing the risk of implant breakage and cut-out of the femoral head.

Convergence has been reported to increase the incidence of non-union. Therefore, placement of parallel peripheral pins, is considered ideal

Bray TJ, Smith-Hoefer E, Hooper A, Timmerman L.

The displaced femoral neck fracture. Internal fixation versus bipolar endoprosthesis. Results of a prospective, randomized comparison. Clin Orthop Relat Res. 1988 May;(230):127-40.

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Finite element analysis

Reduced stress and deformationThe Pinloc Plate reduces high peak loads at the fracture site both on the implants and the implant – bone interface. Stress and deformation in the fracture is reduced with more than 50% compared to isolated Hansson Pins. (Ref. 9-10)

Stiffness – Femoral neck fracture with posterior comminution

The fixation of a femoral neck fracture with posterior comminution was simulated and evaluated. The results showed that the two (2) isolated Hansson Pins had significantly lower stiffness than three (3) Hansson Pins locked in a Pinloc Plate. If three (3) Hansson Pins locked in a Pinloc Plate was used, stresses in the region of the trauma and deformations of the femoral head was significantly reduced.

Torsional rigidity [Nmm/deg] – Femoral neck fracture with posterior comminution

The fixation of a femoral neck fracture with posterior comminution was simulated and evaluated. The results showed that the two (2) isolated Hansson Pins had significantly lower torsional rigidity than three (3) Hansson Pins locked in a Pinloc Plate and thus larger deformations occurred.

The Pinloc Plate acts as a load transmitter.

2 isolated Pins 3 Pins with a Pinloc Plate

High stress Uniform stress

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Biomechanical analysis

Dynamic Validation, standing positionInstron machine at Elos Medtech in Timmersdala. 4:th generation composite bone from sawbones. Dynamic load 1900 N (Ref. 12). Cycles: 1 Hertz. Composites bone: 6 pcs + 6 pcs = 12 pcs. Load correspond to 159º JRF.

Validation

ll 2 isolated Hansson Pins

ll 3 Hansson Pins locked in a Pinloc Plate

Fracture

Transcervical fracture with a 10 mm inferior wedge.

Stop criteria

ll Fracture surfaces compacted

ll Displacement > 9 mm

ll Max 10.000 cycles

Conclusion

The Hansson Pinloc is superior to two (2) isolated Hansson Pins in standing position. (Ref. 11)

2 isolated Hansson Pins in standing position: 1332 cycles until failure

3 Hansson Pins with a Pinloc Plate in standing position: 10.000 cycles without failure

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Reduces the risk of femoral head necrosis

The difference in the incidence of necrosis of the femoral head was significantly lower in the Hook Pin group for displaced fractures (odds ratio 3.5 p = 0.036).

Preserves the blood supplyll Minimum surgical trauma

The smooth profile of the Pins allows for sliding into final positioning without applying torque forces or hammering. This minimizes disruption to the blood supply and the consequent danger of avascular necrosis.

ll Prevents further damage to the lateral epiphyseal arteries By preventing rotation of the femoral head and avoiding the area where the lateral epiphyseal arteries enter the femoral head, the Hansson Pinloc can prevent further damage to the lateral epiphyseal arteries.

Lykke N, Lerud PJ, Strømsøe K, Thorngren KG.

Fixation of fractures of the femoral neck. A prospective, randomised trial of three Ullevaal hip screws versus two

Hansson hook-pins. J Bone Joint Surg Br. 2003 Apr;85(3):426-30.

A Pin is inserted through a drilled hole and atraumatically advanced into the femoral head. The proximal Pins are placed just above the central axis of the femoral neck.

The hook is deployed by turning the introduction screwdriver clock-wise whilst gently pushing medially on the T-handle. This minimizes disruption to the blood supply and the consequent danger of avascular necrosis.

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Preserves bone integrityll Reduced bone disruption

By using only three 6.5 mm Pins, the cancellous bone within the femoral head and neck is preserved.

ll Enters the lateral femoral cortex at a point opposite the lesser trochanter Reducing the risk of subtrochanteric hip fractures.

Minimal invasive surgeryll Small incision

The complete procedure is carried out through a 30-40 mm skin incision.

ll Short procedure Simple instrumentation and a reproducible procedure allows fixation to be achieved within an adequate time frame.

ll Easy extraction The procedure for Pin removal is quick and straightforward. The risk of the Pin being trapped in the bone is reduced as the Pin surface is smooth. The Pin has been treated with anodization type II which prevents bone ongrowth. The hook is easily withdrawn into the body of the Pin, which can then be pulled out.

Three 6.5 mm Pins destroy 21% less bone area than three 7.3 mm cannulated screws.

The Pins can be removed without further disruption to bone. No forces are applied to the femoral head.

Three 7.3 mm cannulated screws = 125.6 mm2

(Shank 4.5-4.8 mm)

Three 6.5 mm Pins = 99.5 mm2

π × r 2 =Total area of destroyed bone

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Pre-op. Garden 1 fracture.

Two days post-op. The patient was operated with the Hansson Pinloc.

Two months post-op. The fracture has found a stable position. ~2 mm shortening.

Pre-op. Garden 2 fracture.

Four days post-op. The patient was operated with the Hansson Pinloc.

One month post-op. The fracture has found a stable position. ~3 mm shortening.

Case 1 Case 2

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1. Mjørud J, Skaro O, Solhaug JH, Thorngren KG. A randomised study in all cervical hip fractures osteosynthesis

with Hansson hook-pins versus AO-screws in 199 consecutive

patients followed for two years. Injury. 2006 Aug;37(8):768-77. Epub 2006 Feb 14.

2. Uta S, Inoue Y, Kaneko K, Mogami A, Tobe M, Maeda M, Iwase H, Obayashi O. Treatment of femoral neck fracture with Hansson

Pins. A biomechanical study. Japan Clinical Biomechanics. 2000; (21):377-83.

3. Strömqvist B, Nilsson LT, Thorngren KG. Femoral neck fracture

fixation with hook-pins. 2-year results and learning curve in 626

prospective cases. Acta Orthop Scand. 1992 Jun;63(3):282-7.

4. Bray TJ, Smith-Hoefer E, Hooper A, Timmerman L. The

displaced femoral neck fracture. Internal fixation versus

bipolar endoprosthesis. Results of a prospective, randomized

comparison. Clin Orthop Relat Res. 1988 May;(230):127-40.

5. Strömqvist B, Hansson LI, Nilsson LT, Thorngren KG. Hook-pin

fixation in femoral neck fractures. A two-year follow-up study of

300 cases. Clin Orthop Relat Res. 1987 May;(218):58-62.

6. Strömqvist B, Hansson LI. Femoral head vitality in femoral neck

fracture after hook-pin internal fixation. Clin Orthop Relat Res.

1984 Dec;(191):105-9.

7. Lykke N, Lerud PJ, Strømsøe K, Thorngren KG. Fixation of

fractures of the femoral neck. A prospective, randomised trial of

three Ullevaal hip screws versus two Hansson hook-pins. J Bone

Joint Surg Br. 2003 Apr;85(3):426-30.

8. Palm H, Gosvig K, Krasheninnikoff M, Jacobsen S, Gebuhr P. A new measurement for posterior tilt predicts reoperation in

undisplaced femoral neck fractures: 113 consecutive patients

treated by internal fixation and followed for 1 year. Acta Orthop.

2009 Jun;80(3):303-7.

9. Jönsson A (MD, PhD), Mellgren M (M.Sc.), Theodorsson J (M.Sc.). Analysis of Hansson Pinloc System for femoral neck

fractures. The fracture gap modeled by a very elastic material.

12702.02.06-TR-01, XDIN® Develop and Deliver. (Data on file)

10. Jönsson A (MD, PhD), Mellgren M (M.Sc.), Theodorsson J (M.Sc.). Torsional rigidity of Hansson Pinloc System for femoral

neck fractures. 12702.02.04-TR-01, XDIN® Develop and Deliver. (Data on file)

11. Jönsson A (MD, PhD), Lannergård A. Biomechanical test –

Hansson Pinloc; standing case. (Data on file)

12. Bergmann G, Deuretzbacher G, Heller M, Graichen F, Rohlmann A, Strauss J, Duda GN. Hip contact forces and gait patterns from

routine activities. J Biomech. 2001 Jul;34(7):859-71. PubMed

PMID: 11410170.

Pre-op. Garden 4 fracture. Hip prosthesis could not be used.Patient is severely sick – High risk of mortality.

One week post-op. The patient was operated with the Hansson Pinloc after a successful reduction.

Two months post-op. The fracture has found a stable position. ~6 mm shortening.

Case 3 References

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Indications

Femoral neck fractures

ll One Plate with three Pins (primary choice)

ll One Plate with two Pins and an Anterior Peg

ll One Plate with two Pins

ll Two isolated Pins (This is covered by a separate brochure)

Slipped capital femoral epiphyses in children

ll One isolated Pin (This is covered by a separate brochure)

ContraindicationsDue to a lack of any supportive clinical experience, the Hansson Pinloc system is not recommended for use with pediatric hip fractures.

The physician’s education, training and professional judgement must be relied upon to choose the most appropriate device and treatment. Conditions presenting an increased risk of implant failure include:

ll Any active or suspected latent infection or marked local inflammation in or about the affected area.

ll Compromised vascularity that would inhibit adequate blood supply to the fracture or the operative site.

ll Bone stock compromised by disease, infection or prior implantation that can not provide adequate support and/or fixation of the devices.

ll Material sensitivity, documented or suspected.

ll Obesity. An obese patient can produce loads on the implant that can lead to failure of the fixation of the device or to failure of the device itself.

ll Patients having inadequate tissue coverage over the surgical site.

ll Implant utilization that would interfere with anatomical structures or physiological performance.

ll Any mental or neuromuscular disorder which would create an unacceptable risk of fixation failure or complications in postoperative care.

ll Other medical or surgical conditions which would preclude the potential benefit of surgery.

Detailed information is included in the instructions for use being provided with each implant. The surgeon must discuss all relevant risks, including the service life of the device and the need for postoperative protection of the implant with the patient, when necessary.

This information is also available on www.swemac.com.

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2. Reduce the fracture

Reduction should be obtained by gentle manipulation according to the normal procedure for displaced fractures. The fracture position should be anatomical or with a slight valgus tilt and held by immobilization on an extension table. The femoral head and neck should be positioned parallel to the floor.

The foot should therefore be rotated inwards and fixed between 15° and 30° of internal rotation. The patella should have an either horizontal or slightly inward position. The patient is then prepared and draped.

Surgical technique1. Position the patient

Place the patient in supine position on an extension table. Position the leg on the healthy side with the hip in flexion and adequate abduction so that the C-arm can be adjusted intraoperatively for both the anterior/posterior view, and the lateral view which is necessary to obtain a true axial view of the femoral neck and head.

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Optimal implant position

The inferior Pin1. Enters the lateral femoral cortex at a point opposite the

lesser trochanter.

2. Touches the internal surface of the medial cortex in the femoral neck below the fracture.

3. Reaches the subchondral bone in the femoral head just below the centre.

The posterior Pin

The posterior Pin is placed parallel to the inferior Pin.

4. Enters the lateral femoral cortex.

5. Touches the internal surface of the posterior cortex of the femoral neck below the fracture.

6. Reaches the subchondral bone of the femoral head.

In a lateral projection the Pin is placed slightly posteriorly to the central femoral axis line.

The anterior Pin

The anterior Pin is placed parallel to the posterior and the inferior Pin.

7. Enters the lateral femoral cortex.

8. Touches the internal surface of the anterior cortex (if possible) of the femoral neck below the fracture

9. Reaches the subchondral bone of the femoral head.

In the lateral projection the Pin is placed slightly anteriorly to the central femoral axis line.

1

2

3

The inferior Pin (1-3).

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8

9

5

6

The posterior Pin (4-6) and the anterior Pin (7-9).

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3. Locate the optimal point for skin incision

The Hansson Pinloc positioning template is temporarily placed onto the monitor of the image intensifier in AP-view. The horizontal line (1) should be at the level, but not below, the lower edge of the lesser trochanter. It is essential to have the 125° line (2) close to the inner inferior cortex. The silhouette of the Plate (3) should be positioned against the lateral cortex.

A Guide Wire is placed along the 125° line (2) under image intensification. A second Guide Wire, is held in a vertical position to the femoral shaft and directed against the point where the 125° line (2) and the skin meet, (A).

A third Guide Wire (the first Guide Wire can be used) is placed along the midline axis of the femoral shaft.

The point where the second and the third Guide Wires cross, (B), is the optimal starting point for the skin incision.

1.

2.

2.

A.

3.

B.

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4. Make incision

A 40 mm longitudinal incision is made, in the proximal direction from point B through the skin. The deep fascia is divided in the direction of the fibres. The lateral cortex of the femur may be approached either directly or posterior-laterally by lifting the vastus lateralis muscle. The area of the femur where the plate is to be positioned is cleared with a raspatorium.

The Guide Wire Sleeve with handle and the Guide Wire is introduced through the incision. A Guide Wire Adapter can be used to facilitate the insertion of the Guide Wires.

5. Introduce the inferior Guide Wire

Once the Guide Wire is aligned with the 125° line of the Hansson Pinloc Positioning Template, the Guide Wire is advanced to the subchondral bone of the femoral head.

In the lateral view, it should be central in relation to the femoral head and neck.

NOTE: The correct insertion of the inferior Guide Wire is critical for the outcome of the procedure. It is important to ensure that the Guide Wire does not penetrate the hip joint.

B.

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6. Drill the inferior canal

Introduce the Cannulated Drill over the Guide Wire and through the Drill Sleeve with handle. A Drill Adapter can be used to facilitate the insertion of the Drills.

Image intensification is used to ensure that the Cannulated Drill follows the Guide Wire accurately and does not cut through the calcar.

The Drill is advanced to the subchondral bone of the femoral head.

The inferior Drill is left in position.

NOTE: It is important to ensure that the Guide Wire or the Drill does not penetrate the hip joint.

If drilling is carried out over a bent Guide Wire, there is a high risk of femoral head penetration.

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7. Select and introduce the Parallel Guide

There are three Parallel Guides with different distances between the sleeves (6, 8 or 10 mm).

Select the Parallel Guide which gives the widest possible separation of the Pins without cutting through the posterior or anterior cortex.

The fixed Guide Wire Sleeves of the Parallel Guide has the same outer diameter as the Hansson Pin (Ø 6.5 mm). It is therefore possible for the surgeon to assess if the Hansson Pins can be inserted through the femoral neck without cutting through the posterior and/or the anterior cortex. Based on this assessment the correct plate can be selected. If unsure, start by introducing the 8 mm Parallel Guide.

In the frontal view the posterior Guide Wire should be positioned just above the center of the femoral neck and head. It is important to avoid the area where the laterial epiphyseal arteries enter the femoral head (A).

The selected Parallel Guide is pushed over the inferior Drill and rotated, to ensure that the posterior Guide Wire is situated posteriorly and proximaly.

The teeth of the Parallel Guide are pushed into the cortex to enhance stability.

A.

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8. Introduce the posterior Guide Wire

Once the alignment of the Guide Wire is satisfactory, the Guide Wire is advanced to the subchondral bone of the femoral head.

If the Guide Wire bends

If the Guide Wire touches the internal posterior cortex and bends, it is important to remove the Guide Wire and rotate the Parallel Guide in such a way that it is possible to reinsert the Guide Wire parallel to the inferior Drill. If necessary, select a smaller Parallel Guide.

NOTE: If drilling is carried out over a bent Guide Wire, there is a high risk of femoral head penetration.

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9. Introduce the anterior Guide Wire

The anterior Guide Wire is introduced through the Parallel Guide.

Once the alignment of the Guide Wire is satisfactory, the Guide Wire is advanced to the subchondral bone of the femoral head.

NOTE: If the femoral neck is too narrow to allow insertion of an anterior Hansson Pin, a short Anterior Peg can be inserted to stabilize the lateral cortex without passing through the femoral neck.

10. Assemble the Pinloc Plate and the Drill Sleeves

Place the chosen Pinloc Plate in the corresponding plate holder (inside the instrument set). introduce the three Drill Sleeves over the pegs into the threaded holes of the selected plate. The Drill Sleeve Handle is used to tighten the Drill Sleeves.

The assembled Pinloc Plate is introduced over the inferior Drill and the proximal Guide Wires.

Drill Sleeve

Pinloc Plate

Drill Sleeve Handle

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11. Drill the posterior canal

The second Cannulated Drill is introduced over the posterior Guide Wire.

Image intensification is used to ensure that the Drill does not cut through the posterior cortex. The Drill is advanced to the subchondral bone of the femoral head.

The posterior Drill is left in position.

12. Drill the anterior canal

The third Cannulated Drill is introduced over the anterior Guide Wire.

Image intensification is used to ensure that the Drill does not cut through the anterior cortex. The Drill is advanced to the subchondral bone of the femoral head.

The anterior Drill is left in position.

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13. Measure the inferior canal

The required Pin length is read off the scale on the Measuring Sleeve against the end of the Cannulated Drill protruding from the inferior Drill Sleeve. If the measured value is between two pin lengths, always choose the shorter pin length. Make sure that the Pinloc Plate is in contact with the bone when reading the scale.

The drilling depth can be adjusted manually if possible, using the Tri-lobe Driver Handle attached to the Cannulated Drill. The Drill Sleeve Handle is used to push the Pinloc Plate forward when reading the length against the Drill Sleeve. The Tri-lobe Driver Handle can be used to remove the Cannulated Drill. The inferior Drill Sleeve can then be removed.

14. Instrument-to-Pin Assembly

Mount the Pin on the T-handle Hex Verify that the Inner Pin does not protrude from the window of the Outer Body and is in correct position. The T-handle Hex is introduced into the Pin.

There are several arrows (guide lines) on the T-handle Hex that when introduced into the outer Pin should be in line with the window of the outer Pin to ensure the direction in which the hook will be deployed.

T-handle Hex 6.0 mm

Hansson Pin

Screwdriver Hex 3,0 mm

Tri-lobe Driver Handle

T-handle Hex + Hansson Pin

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Step 1The Pin is introduced into the Plate and rotated as far as it will go.

Step 2The screwdriver handle is introduced into the T-handle Hex and rotated as far as it will go. This will deploy the hook.

T-handle Hex + Hansson Pin

Do not hammer on the T-handle Hex during insertion of the Pin.

Do not over-tighten the introduction screw.

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15. Introduce the inferior Pin

If necessary, use suction to remove bone substance trapped in the threads of the inferior hole. A Pin of the length required for the inferior canal is mounted on the T-handle Hex and inserted into the inferior pre-drilled canal. The T-handle Hex is turned clockwise as far as it will go.

When the Pin is properly locked in the Pinloc Plate, the hooks will automatically point towards the center of the femoral head. Ensure that the Pin is fully inserted and in good position using image intensification.

NOTE: Do not remove the T-handle Hex before deploying the hook.

16. Deploy the hook of the inferior Pin

Assemble the Screwdriver Hex and the Tri-lobe Driver Handle. Insert the tip of the assembled screwdriver through the hole in the T-handle Hex. The hook is deployed by turning the assembled screwdriver whilst pushing medially on the T-handle Hex.

Continue turning the assembled screwdriver to completely deploy the hook using image intensification. The hook is fully extruded when the introduction screw reaches its mechanical stop. After deployment of the hook, the introducer assembly shall be removed.

NOTE: Do not over-tighten the introduction screw.

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17. Introduce the posterior Pin and then the anterior Pin

The same procedure as used when measuring the length and introducing the inferior Pin (steps 12-15) are repeated when introducing the posterior and then the anterior Pin.

Lateral view.

18. Check the position of the Pins

Before closing the skin incision, it is important to make sure that none of the Pins have penetrated the joint. This can be done by removing traction and rotating the hip under image intensification in both AP and lateral view.

Lateral view.

Postoperative regimeFull weight-bearing as tolerated by the patient may be allowed in elderly patients. In younger patients, partial weight-bearing is preferable.

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Implant extraction1. Retract the hook of the inferior Pin

Image intensification is used to locate the Plate and a 40 mm skin incision is made. The T-handle Hex is introduced into the inferior Pin. The Screwdriver Hex and the Tri-lobe Driver Handle are assembled.

The assembled screwdriver is introduced into the T-handle Hex and rotated counter-clockwise to retract the hook.

2. Remove the inferior Pin

Check under image intensification that the hook is fully retracted prior to the removal of the Pin. The Pin is removed by rotating the T-handle Hex counter-clockwise. Once the hook is fully retracted, the Pin is removed along with the assembled extractor.

The same procedure as used when removing the inferior Pin (steps 1-2) is repeated when removing the posterior and then the anterior Pin.

In patients with poor bone quality, It is possible to remove the Plate together with all Pins after retraction of the hooks.

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Product informationCAT. NR. IMPLANTS

HANSSON PINS

62-0070S Hansson Pin | length 70 mm














PLATES

62-2006S Plate | 6 mm

62-2008S Plate | 8 mm

62-2010S Plate | 10 mm

ANTERIOR PEG

62-0040S Anterior Peg | length 40 mm

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INSTRUMENTS

62-3004S Guide Wire | Ø3.2 mm | length 300 mm 62-3004N

72-2004 Guide Wire | Ø3.2 mm | length 300 mm

62-3010 Drill Sleeve | Ø6.7 mm

62-3013 Solid Drill | Ø6.7 mm

62-3014 Cannulated Drill | Ø6,7 mm

72-2016 Handle for Drill Sleeve

62-3020 Screwdriver Hex | Q-Loc | 3,0 mm

62-3022 T-handle Hex | 6,0 mm

62-3036 Guide Wire Sleeve with handle

62-3038 Drill Sleeve with handle

62-3094 Drill Adapter | Q-Loc

62-3034 Guidewire Adapter | Q-Loc

62-3090 Tri-Lobe Driver Handle | Q-Loc

62-3056 Parallell Guide | 6xØ3,2 mm

62-3058 Parallel Guide | 8xØ3,2 mm

62-3060 Parallel Guide | 10xØ3,2 mm

62-3062 Measuring Sleeve

62-3100 Hansson Pinloc Positioning Template

62-1000 Tray

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Instruction For Use – Osteosynthesis implant, non active implant

FURTHER INFORMATIONThis Instruction For Use leaflet is only provided in English. Other languages of this leaflet and the recommended surgical technique as well as detailed instructions for cleaning, sterilization and re-sterilization can be downloaded in PDF format from the Swemac website http://www.swemac.com/ifu/IFU-0102/. Printed documentation can be provided free of charge upon request. Delivery time is max 7 days.

DESCRIPTIONThe Hansson Pinloc system is an implant system intended for temporary stabilization of femoral neck fractures in adults until bone consolidation has been achieved and for treatment of slipped capital femoral epiphysis in children. The implants are single use devices, made of implantable Ti6Al4V (ISO 5832-3). The system consists of three pins intended to be used together with a plate. The pins and plates are available in different sizes. The system includes specific instruments for the procedure. The device is for professional use only.

COMPATIBILITYThe implants are safe for the patient undergoing an MR procedure, but depending on the implant materials, image artifacts may occur.

INDICATIONS Femoral neck fractures in adults:

• One plate with three pins (primary choice)• One plate with two pins and a peg• One plate with two pins• Two isolated pins

Slipped capital femoral epiphysis in children:

• One isolated pin

CONTRAINDICATIONSThe physician’s education, training and professional judgment must be relied upon to choose the most appropriate device and treatment. Conditions presenting an increased risk of failure include:

• Any active or suspected latent infection, sepsis or marked local inflammation in or around the surgical area.

• Severe osteoporosis, insufficient quantity or quality of bone/soft tissue.• Material sensitivity documented or suspected.• Physical interference with other implants during implantation or use.• Obesity. An obese patient can produce loads on the implant that can lead to

device/treatment failure.• Compromised vascularity, inadequate skin or neurovascular status.• Compromised bone stock that cannot provide adequate support and/or

fixation of the device due to disease, infection or prior implantation.• Patients who are unwilling or incapable of following post-operative care

instructions.• Other physical, medical or surgical conditions that would preclude the

potential benefit of surgery.

WARNINGS: • Do not use the device without reading the surgical manual,

which has been provided to the clinic separately.• Do not use The Hansson Pinloc System with paediatric hip fractures.• The device must only be used by a professional surgeon who is thoroughly

familiar with the implant, the methods of application, instruments, and the recommended surgical technique of the device.

• The correct selection of the fracture fixation application is extremely important. Failure to use the appropriate application for the fracture condition may accelerate clinical failure. Failure to use the proper component to maintain adequate blood supply and provide rigid fixation may result in loosening, bending, cracking or fracture of the device and/or bone.

• The implant can be available in different sizes and versions. It is important to select the appropriate combination of implant components and sizes taking in to consideration the length, body weight, anatomy and functional demands of the patient. Implants which consist of several components must only be used in the prescribed combination (see surgical manual).

• Improper insertion of the device during implantation can increase the possibility of loosening or migration.

• Improper positioning of the device may lead to clinical failure.• It is important to ensure that the guide wire or the drill does not penetrate the

hip joint.• Do not reuse the implants, since previous stresses may have created

imperfections, which can lead to a device failure.• Do not touch sharp edges of instruments or implants.• The device is not designed to immediately withstand the stress of weight

bearing, load bearing, or excessive activity.• If either the product or package seems damaged, contaminated or if sterility

is questioned for any reason, the product shall not be used.• Do not reuse Guide Wires, these are single use only. Guide Wires may be

damaged of bent during surgical procedures. If a Guide Wire is reused it may become lodged in the instruments or the drill and could be advanced in to the

pelvis, damaging large blood vessels or vital organs.• Drills and reamers with measuring function must not be re-sharpened.• Do not over-tighten the introduction screw.

PRECAUTIONS• Ensure that all components needed for the operation are available in the

surgical theatre.• Inspection is recommended prior to surgery to determine if implants have

been contaminated or damaged during storage.• Instruments should be examined for wear or damage prior to surgery.• Avoid surface damage to the implant and discard all damaged or mishandled

implants.• After the procedure check the proper positioning of all implants using an

image intensifier. Correct positioning of the implant parts is extremely important for the outcome (see surgical manual).

• Do not use components from Swemac in combination with components from other manufacturer’s system.

ADVERSE EFFECTS • Pain, discomfort, abnormal sensations, nerve damage, soft tissue damage,

infections, necrosis of bone, bone resorption, necrosis of the tissue or inadequate healing may result from the presence of an implant or due to surgical trauma.

• Treatment failure such as fracture or loosening of the implant may occur due to excessive activity, prolonged loading upon the device, incomplete healing, delayed union, non-union or excessive force exerted on the implant during insertion.

• Implant migration and/or loosening may occur.• Mal-union may occur.• Shortening of the affected bone/fracture site.• Metal sensitivity, histological or allergic reaction resulting from implantation of

a foreign material may occur.

POSTOPERATIVE CARE INSTRUCTIONS: Postoperative care is extremely important. The patient must be cautioned about the use, limitations and possible adverse effects of this implant. The patient must also be warned that the implant and/or treatment might fail if he/she neglects the postoperative care instructions.

• The implantation affects the patient’s ability to carry loads and her/his mobility and general living circumstances. For this reason, each patient needs individual instructions on correct behavior after implantation.

• The device is not designed to immediately withstand the stress of weight bearing, load bearing or excessive activity.

• Explain the need to report unusual changes in the implantation area as well as falls or accidents even if the device or the surgical area did not appear to be harmed at the time.

STERILITYThe implants are provided sterile or non-sterile.

Sterile devices have been exposed to a minimum dose of 25.0 kGy gamma irradiation. If either the implant or the package appears damaged, or if sterility is questioned for any reason, the implant shall not be used.

Non-sterile implants must be sterilized by using a validated sterilization process following EN ISO 17665 prior to use.

CLEANING AND DISINFECTIONThe instruments should be disassembled before cleaning. Cleaning shall be performed in accordance with ISO 15883. Cannulated instruments must be visually inspected after cleaning.

STERILIzATION AND RE-STERILIzATION OF INSTRUMENTS

The instruments and non-sterile implants shall be sterilized and re-sterilized by using a validated sterilization process in accordance with ISO 17665. Sterile packaging shall be done in accordance to EN-ISO 11607-1.

The following sterilization parameters are recommended

134 °C for min. 3 minutes*

121 °C for min. 15 minutes*

* Holding time. These times do not include air removal or penetration times.

STORAGE INSTRUCTIONS Store in a cool dry place and keep away from direct sunlight. Prior to use, inspect the product package for signs of tampering, or water contamination.

Sterilized by radiation Do not use if package is damaged

Do not reuse

SYMBOLS USED ON THIS DEVICE

Consult instruction for use

Warning Non-sterile

CAUTION: Federal law (USA) restricts this device to sale by or on order of a licensed physician or hospital

Manufacturer: Swemac Innovation AB 0413 Industrigatan 11 • SE-582 77 Linköping • Sweden

P102-28-3S-T-20130704

Print date: 2013-07-04

Hansson Pinloc System

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