Distal Fibula Plate SURGICAL TECHNIQUE

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MAXLOCK EXTREME Distal Fibula Plate SURGICAL TECHNIQUE

Contents Key Design Features 3 Surgical Technique 4 Implants and Instruments 8 Proper surgical procedures and techniques are the responsibility of the medical professional. The following guidelines are furnished for information purposes only. Each surgeon must evaluate the appropriateness of the procedures based on his or her personal medical training and experience. Prior to use of the system, the surgeon should refer to the product package insert for complete warnings, precautions, indications, contraindications and adverse effects. Package inserts are also available by contacting Wright Medical. Please contact your local Wright representative for product availability. 2

Key Design Features The Distal Fibula plate is designed to match the morphometry of the fibula lateral malleolus for fixation of Weber type A, B and C fractures. Better anatomical fit may lead to more secure fracture fixation and return to natural bony anatomy and function. The plate comes in side and size specific configurations. Four (4) distal screw holes are designed to allow capture of the most distal fracture fragments. The Distal Fibula plate utilizes locking screw technology. Surgeon has the choice of locking or nonlocking screws. Translation slot permits angle & position variability in placing transsyndesmotic screw fixation. The Distal Fibula plate is thinner than the competitive products. This reduced profile is intended to reduce overlying tissue irritation while still providing adequate construct strength. 3

Surgical Technique Step 1 The patient is placed in a supine position with a bolster under the ipsilateral hip to aid exposure of the lateral ankle. A lateral incision is made at the midline of the distal fibula. Care is taken to avoid injury to a distally positioned intermediate dorsal cutaneous nerve. The fracture is reduced and held with a clamp. Fluoroscopy can be used to assess reduction of the fibula fracture and ankle mortise. Step 2 Once fracture reduction is achieved, the contoured and low profile distal fibular plate is applied with the longer distal ear of the plate being oriented posteriorly. The correct length of the plate is determined. CAUTION: In pediatric patients, avoid crossing the growth plate with any implants. 4

Step 3 If necessary, use the plate bending irons or plate bending pliers to contour the plate to the bone surface. When using the plate bending irons, use your thumbs to apply pressure to the top while pulling apart at the bottom. Use the top slots to concave the plate and the bottom slots to convex the plate. Each bend should be in one direction only. Reverse or over bending may cause reduced fatigue life. Avoid excessive bending through the locking holes. If the plate is contoured through the locking holes, a nonlocking screw is recommended to avoid crossthreading of the locking screw. Step 4 Once the plate is positioned on the fibula, olive wires can be used to hold the plate in position while the initial screws are placed proximally and distally. Ideally, 4-screw fixation on each side of the fracture should be considered for optimal fracture fixation stability. If the fracture is comminuted, span the unstable fragments with a longer plate that still allows 4-screw fixation in the proximal and the most distal fragments. The surgeon may choose to use an interfragmentary compression screw outside the plate initially to stabilize the main boney fragments. CAUTION: The trajectories of the 4 distal holes of the plate converge. There is a potential for these screws to intersect if the selected screw length is too long, nonlocking screw trajectories are too divergent from the hole axes, and/or the plate is over contoured. Screw collision could compromise construct fixation, cause the screw head to sit proud, and/or damage the implant. Four locking screws of 18 mm length in the distal portion of an unaltered plate will not contact each other. Interoperative imaging should be consulted for distal constructs that utilize a longer screw(s), an off axis nonlocking screw, and/or a plate contoured to a smaller radius of curvature.) 5

Step 5 The screw holes in the plates are compatible with a variety of screw options. Non-locking 2.7 mm, 3.5 mm and 4.0 mm screws are offered and can be used in either the screw hole or the slot. 3.5 mm fixed-angle locking screws are provided for only the threaded locking holes. Screw diameter is chosen based on indication and surgeon preference; a combination of screws may be used in the same plate. For fractures with comminution, locking screws have the theoretical advantage of providing greater stability of fixation. The non-locking screws have the advantage of greater conical freedom of screw positioning when attempting to gain screw purchase in smaller, comminuted bone fragments. The 3.5 mm screws are available in locking and non-locking options. Larger (4.0 mm) screws are available for greater purchase and pullout strength in those patients with softer bone or when greater purchase or pullout strength is desired. Five color-coded drill bits are provided in the system. 1.9 mm (gold), 2.4 mm (magenta) and 2.7 mm (aqua) diameters are the standard drill bits. The 1.9 mm bit is to be used in conjunction with the 2.7 mm screws, the 2.4 mm bit is to be used in conjunction with the 3.5 mm screws, and the 2.7 mm bit is to be used in conjunction with the 4.0 mm screws. A 3.5 mm (double-banded magenta) drill bit and 4.0 mm (double-banded aqua) drill bit are also provided and can be used for lag screw technique. Step 6 To drill for non-locking screws, use the drill guide handle with the appropriate size centered drill guide tip. The drill guide tips are color coded to match the appropriate drill bit and screw diameter. When drilling for a locking screw, either the Fixed Drill Guide or the Keyway Drill Guide should be used. The Fixed Drill Guide threads into the locking hole to provide the proper angle for drilling. To use the Keyway Drill Guide, align the lobes on the tip of the guide with the lobes in the threaded hole and press into the plate while drilling to ensure proper alignment. Note: When lag technique is desired, use the lag drill bit with the corresponding centered drill guide tip to over-drill the gliding hole. 6

Step 7 Drill to desired depth. Take care to not move the plate after drilling for a locking hole in order to maintain the proper pilot hole alignment and prevent locking screw cross-threading. Step 8 Use only the provided depth gauge to determine screw length. For all screws used throughout the procedure, verify screw length in the gauge on the screw caddy. Note: The depth gauge reading corresponds to the working length of the screw (from distal tip to underneath the screw head). Step 9 Use the HEXSTAR driver to insert the screw. Drill and insert remaining screws. Note: Do not over torque the screws. 7

Step 10 If there is concern about possible instability of the syndesmosis, stressing the ankle mortise by externally rotating the foot during fluoroscopy will help assess the integrity of the deltoid and syndesmotic ligaments. If shifting of the talus laterally in the mortise of 1-2 mm or more is seen, two 4.0 mm screws can be placed in the slots of the plate above the level of the ankle joint to provide fixation. With the fibula anatomically reduced in the Incisura fibularis of the distal tibia, the larger screws are inserted to provide stable three-cortex fixation of the syndesmosis. Step 11 Close the soft tissue as required by the operative procedure and surgeon preferred technique. (Lateral View) Implants and Instruments PLATES Description Part # Long Left Plate Long Right Plate Medium Left Plate Medium Right Plate Short Left Plate Short Right Plate Olive Wire DFX-002-LL DFX-002-LR DFX-002-ML DFX-002-MR DFX-002-SL DFX-002-SR MFT-040 ø1.1 mm K-Wire MFT-040-11-SS 8

SCREWS 2.7 mm Non-Locking Screws Description Part # ø2.7 8 mm Non-locking Screw MFT-011-27-08 ø2.7 10 mm Non-locking Screw MFT-011-27-10 ø2.7 12 mm Non-locking Screw MFT-011-27-12 ø2.7 14 mm Non-locking Screw MFT-011-27-14 ø2.7 16 mm Non-locking Screw MFT-011-27-16 ø2.7 18 mm Non-locking Screw MFT-011-27-18 ø2.7 20 mm Non-locking Screw MFT-011-27-20 ø2.7 22 mm Non-locking Screw MFT-011-27-22 ø2.7 24 mm Non-locking Screw MFT-011-27-24 ø2.7 26 mm Non-locking Screw MFT-011-27-26 ø2.7 28 mm Non-locking Screw MFT-011-27-28 ø2.7 30 mm Non-locking Screw MFT-011-27-30 3.5 mm Non-Locking Screws Description Part # ø3.5 8 mm Non-locking Screw MFT-011-35-08 ø3.5 10 mm Non-locking Screw MFT-011-35-10 ø3.5 12 mm Non-locking Screw MFT-011-35-12 ø3.5 14 mm Non-locking Screw MFT-011-35-14 ø3.5 16 mm Non-locking Screw MFT-011-35-16 ø3.5 18 mm Non-locking Screw MFT-011-35-18 ø3.5 20 mm Non-locking Screw MFT-011-35-20 ø3.5 22 mm Non-locking Screw MFT-011-35-22 ø3.5 24 mm Non-locking Screw MFT-011-35-24 ø3.5 26 mm Non-locking Screw MFT-011-35-26 ø3.5 28 mm Non-locking Screw MFT-011-35-28 ø3.5 30 mm Non-locking Screw MFT-011-35-30 ø3.5 32.5 mm Non-locking Screw MFT-011-35-325 ø3.5 35 mm Non-locking Screw MFT-011-35-35 ø3.5 37.5 mm Non-locking Screw MFT-011-35-375 ø3.5 40 mm Non-locking Screw MFT-011-35-40 ø3.5 42.5 mm Non-locking Screw MFT-011-35-425 ø3.5 45 mm Non-locking Screw MFT-011-35-45 ø3.5 47.5 mm Non-locking Screw MFT-011-35-475 ø3.5 50 mm Non-locking Screw MFT-011-35-50 9

SCREWS 3.5 mm Fixed Angle Locking Screws Description Part # ø3.5 8 mm Fixed Angle Locking Screw MFT-021-35-08 ø3.5 10 mm Fixed Angle Locking Screw MFT-021-35-10 ø3.5 12 mm Fixed Angle Locking Screw MFT-021-35-12 ø3.5 14 mm Fixed Angle Locking Screw MFT-021-35-14 ø3.5 16 mm Fixed Angle Locking Screw MFT-021-35-16 ø3.5 18 mm Fixed Angle Locking Screw MFT-021-35-18 ø3.5 20 mm Fixed Angle Locking Screw MFT-021-35-20 ø3.5 22 mm Fixed Angle Locking Screw MFT-021-35-22 ø3.5 24 mm Fixed Angle Locking Screw MFT-021-35-24 ø3.5 26 mm Fixed Angle Locking Screw MFT-021-35-26 ø3.5 28 mm Fixed Angle Locking Screw MFT-021-35-28 ø3.5 30 mm Fixed Angle Locking Screw MFT-021-35-30 ø3.5 32.5 mm Fixed Angle Locking Screw MFT-021-35-325 ø3.5 35 mm Fixed Angle Locking Screw MFT-021-35-35 ø3.5 37.5 mm Fixed Angle Locking Screw MFT-021-35-375 ø3.5 40 mm Fixed Angle Locking Screw MFT-021-35-40 ø3.5 42.5 mm Fixed Angle Locking Screw MFT-021-35-425 ø3.5 45 mm Fixed Angle Locking Screw MFT-021-35-45 4.0 mm Non-Locking Screws Description Part # ø4.0 8 mm Non-locking Screw MFT-011-40-08 ø4.0 10 mm Non-locking Screw MFT-011-40-10 ø4.0 12 mm Non-locking Screw MFT-011-40-12 ø4.0 14 mm Non-locking Screw MFT-011-40-14 ø4.0 16 mm Non-locking Screw MFT-011-40-16 ø4.0 18 mm Non-locking Screw MFT-011-40-18 ø4.0 20 mm Non-locking Screw MFT-011-40-20 ø4.0 22 mm Non-locking Screw MFT-011-40-22 ø4.0 24 mm Non-locking Screw MFT-011-40-24 ø4.0 26 mm Non-locking Screw MFT-011-40-26 ø4.0 28 mm Non-locking Screw MFT-011-40-28 ø4.0 30 mm Non-locking Screw MFT-011-40-30 ø4.0 32.5 mm Non-locking Screw MFT-011-40-325 ø4.0 35 mm Non-locking Screw MFT-011-40-35 ø4.0 37.5 mm Non-locking Screw MFT-011-40-375 ø4.0 40 mm Non-locking Screw MFT-011-40-40 ø4.0 42.5 mm Non-locking Screw MFT-011-40-425 ø4.0 45 mm Non-locking Screw MFT-011-40-45 ø4.0 47.5 mm Non-locking Screw MFT-011-40-475 ø4.0 50 mm Non-locking Screw MFT-011-40-50 ø4.0 55 mm Non-locking Screw MFT-011-40-55 ø4.0 60 mm Non-locking Screw MFT-011-40-60 10

INSTRUMENTS Description Part # Plate Bending Pliers MXS-051 Bending Irons MXL-050 60 mm Depth Gauge CAT-059-60 ø2.4 mm Fixed Guide w/ Depth Gauge MFT-071-24-FDG ø2.4 mm Keyway Drill Guide MFT-071-24-KG Ratcheting Handle DRV-057 Non-Ratcheting Handle MFT-057 HEXSTAR Driver Tapered MXS-056-T ø1.9 mm Drill Bit MFT-072-19 ø2.4 mm Drill Bit MFT-072-24 ø2.7 mm Drill Bit MFT-072-27 ø3.5 mm Lag Drill Bit MFT-072-35 ø4.0 mm Lag Drill Bit MFT-072-40 Drill Guide Handle MFT-171 ø1.9 mm Centered Guide Tip MFT-171-19-C ø1.9 mm Offset Drill Guide Tip MFT-171-19-O ø2.4 mm Centered Guide Tip MFT-171-24-C ø2.4 mm Offset Drill Guide Tip MFT-171-24-O ø2.7 mm Centered Guide Tip MFT-171-27-C ø2.7 mm Offset Drill Guide Tip MFT-171-27-O ø3.5 mm Centered Guide Tip MFT-171-35-C ø4.0 mm Centered Guide Tip MFT-171-40-C 11

1023 Cherry Road Memphis, TN 38117 800 238 7117 901 867 9971 www.wright.com 10801 Nesbitt Avenue South Bloomington, MN 55437 888 867 6437 952 426 7600 www.tornier-us.com Trademarks and Registered marks of Wright Medical Group N.V. or its affiliates. 2016 Wright Medical Group N.V. or its affiliates. All Rights Reserved. MXE 801-010 Rev B ECN 160600 13-Apr-2016