Medial Distal Tibia Medial and Malleolus Plates SURGICAL TECHNIQUE

Transcription

1 MAXLOCK EXTREME Medial Distal Tibia Medial and Malleolus Plates SURGICAL TECHNIQUE

2 Contents Key Design Features Medial Distal Tibia Plates 3 Medial Malleolus Plate 7 Surgical Technique Medial Distal Tibia Plates 4 Medial Malleolus Plate 8 Implants and Instruments 12 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

3 Key Design Features The Medial Distal Tibia Plate is an anatomically contoured plate that is designed to sit anteriorly in order to avoid impingement of the posterior tibial tendon across a range of patients. The Medial Distal Tibia Plate has a minimal profile with localized thickening for stabilization. The plate is designed for fixation of distal tibia fractures requiring more stability than traditional screw fixation such as OTA type 43B and certain OTA 44 Series oblique fractures of the medial malleolus. Three plate lengths are available for selection based on fracture location. Screw hole design placement 2 5 The distal screw hole cluster is designed to be divergent to straddle the syndesmosis and run parallel to the joint line. Screw hole design placement 6 The metaphyseal flare screw has a distal angulation to allow manipulation of distal fragments. Screw hole design placement 7 11 The metaphysis screws feature converging screws, utilizing biplanar fixation, to increase rotational stability. 3

4 Surgical Technique Step 1 The patient is placed in a supine position with a bolster under the contralateral hip to aid in exposure to the medial ankle. A medially based ankle incision is utilized to expose the distal tibia and medial malleolus. Care is taken to avoid the posterior tibial tendon and the posteriormedial neurovascular bundle. The fracture is reduced and held in position with a reduction clamp or provisional fixation. Fluoroscopy can be used to assess the reduction of the medial malleolus and ankle joint. Step 2 Once the fracture is adequately reduced, select the appropriate length distal tibia plate and place it across the fracture. This can be done through an open incision or through a minimally invasive incision using an elevator to free soft tissues proximally. Choose a plate that will allow adequate screw placement in order to obtain stable fixation. To ease identification, plates have been color coded per side specification (magenta for Right and green for Left) and have been etched and marked with a R or L to indicate side. The distal end of the plate is marked by a cluster of 5 screw holes. The distal most screw hole is located anteriorly towards the anterior colliculus. CAUTION: In pediatric patients, avoid crossing the growth plate with any implants. Step 3 If necessary, use the plate bending pliers to contour the plate to the bone surface. 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 non-locking screw is recommended to avoid crossthreading of the fixed angle locking screw. Care must be taken not to scratch or notch the implants throughout the procedure. Step 4 Secure the plate to the distal fragment using a combination of a single screw, olive wire, or a k-wire through the k-wire hole. The fixation method chosen will depend on the fracture location. 4

5 Step 5 Align the fragment to the intact portion of the articular surface and confirm placement under fluoroscopy. An interfragmentary screw is recommended to stabilize and compress the main bony fragments. A MAXLOCK EXTREME solid 4.0 mm screw can be used for Interfragmentary Stabilization. Note: It is not recommended to use a 4.0 mm Cannulated Screw through any plate hole. Step 6 Once the fragment is positioned on the tibia, olive wires can be used to hold the plate in position while the screws are placed proximally and distally. The screw holes in the plates are compatible with a variety of screw options. Non-locking screw options include: 2.7 mm, 3.5 mm and 4.0 mm. Locking screw options include: 3.5 mm fixed-angle locking and 3.5 mm variable-angle locking. Reference the variable-angle locking screw technique (MXE ) if variableangle screws are desired. Screw diameter and type is chosen based on indication and surgeon preference; a combination of screws may be used in the same plate. Five drill bits are provided in the system. The standard bits are: 1.9 mm (gold), 2.4 mm (magenta) and 2.7 mm (aqua) diameters. The 1.9 mm bit is to be used in conjunction with 2.7 mm screws and the 2.4 mm bit is to be used in conjunction with 3.5 mm screws and the 2.7 mm bit is to be used in conjunction with 4.0 mm screws. A 3.5 mm (double banded magenta ring) and a 4.0 mm (double banded teal ring) drill bit are also found in the system and can be utilized for lagging the 3.5 mm and 4.0 mm screws. 5

6 Step 7 To drill for a non-locking screw, the centered drill guide tips should be used in conjunction with the drill guide handle. The centered drill guides are color coded to match the appropriate drill bit and screw diameter. When a lag technique is desired, use the 3.5 mm or the 4.0 mm drill guide tips (double banded). Step 8 To drill for a fixed angle locking screw, use the locking guide. The locking guide threads into the locking hole to provide the proper angle for drilling. Note: Take care to not move the plate after drilling for a fixed angle locking screw hole in order to maintain the proper pilot hole alignment and prevent locking screw cross-threading. Step 9 Drill to desired depth. 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. Use the HEXSTAR driver to insert the screw into the hole and drive the screw. Note: The depth gauge reading corresponds to the working length of the screw (from distal tip to underneath the screw head). Step 10 It is recommended that the surgeon use fluoroscopy to verify screw length and placement. Place the remaining screws as needed for adequate fixation. Note: Do not over torque the screws. Driver or implant damage may result. Step 11 Close the soft tissues as required by the operative procedure and surgeon preferred technique. 6

7 Key Design Features The MAXLOCK EXTREME Medial Malleolus Plate is an anatomically contoured locking plate designed to fit the medial aspect of the distal tibia. This low profile plate is intended to act as a buttress and offer an alternative to traditional lag screw fixation for transverse medial malleolar fractures. A single plate has been designed to fit both right and left operative sides. The threaded holes in the Medial Malleolus Plate feature MAXLOCK EXTREME TRIBRID Technology, which accommodates the use of non-locking, fixed-angle locking or variable-angle locking screws for fixation without compromise. Special Note: The Medial Malleolus Plate is available in either the MAXLOCK EXTREME Distal Tibia Plate Caddy or the MAXLOCK EXTREME Fracture Set. These sets are both used in conjunction with standard MAXLOCK EXTREME screws and instrumentation. If the plate is received in the Fracture Set, ensure that a MAXLOCK EXTREME Tray is available at the time of surgery. Chamfered leading edge 2 mm compression slot Distal screw position designed to capture the distal bone fragment while avoiding the ankle joint 7

8 Step 1 The patient is placed in supine position with a bolster under the contralateral hip to aid in exposure to the medial ankle. A medially based ankle incision is utilized to expose the medial malleolus. Care is taken to avoid the posterior tibial tendon and the posterior medial neurovascular bundle. The fracture is reduced and held in position using the surgeon s preferred technique. Step 2 Once the fracture is reduced, place the Medial Malleolus Plate directly over the medial aspect of the distal tibia such that it spans the fracture line. The plate may be temporarily fixed using the provided olive wires. Note: If plate bending is required, use the provided bending pliers to contour the plate to the bone surface. WARNING: Bending should only be done in one direction. Avoid excessive bending through the locking holes. If the plate is bent through a locking hole, a non-locking screw is recommended to avoid cross-threading of a locking screw. Care must be taken not to scratch or notch the implants throughout the procedure. 8

9 Step 3 Drill a pilot hole through one of the distal holes using the appropriately sized drill guide and drill bit. Instruments are color-coded to match each screw size. This technique illustrates use of 3.5 mm non-locking screws distally to compress across the fracture site. Drill through the guide using the 2.4 mm drill bit. It is recommended that the 2.4 mm fixed drill guide is used even when drilling for a non-locking screw. If deviating from prescribed trajectory, take care to avoid drilling through the ankle joint. Note: When drilling for a fixed-angle locking screw, take care not to move the plate after drilling in order to maintain proper pilot hole alignment and prevent locking screw cross-threading. Note: The threaded screw holes in the plate are compatible with a variety of screw options; 2.7 mm non-locking (gold), 3.5 mm non-locking or fixed-angle locking screws (magenta) and 4.0 mm non-locking screws (teal) are included in the MAXLOCK EXTREME set. Depending on surgeon preference, a combination of screw types can be used. 3.5 mm variable-angle locking screws may also be used in the plates; however the variable screw caddy must be present at the time of surgery. Reference the variable-angle locking screw technique guide (MXE ) if variable-angle locking screws are desired. WARNING: Do not use any other manufacturer s screws with Wright Medical plates. Step 4 If utilization of the lag screw technique is preferred, utilize the appropriately sized double-banded lag drill bit to over-drill the near fragment. Note: If working out of the MAXLOCK EXTREME Fracture Set, a 4.0 mm Partially Threaded Screw may alternatively be used to facilitate compression across the fracture site. Step 5 Determine the screw length using the provided depth gauge. For all screws used throughout the procedure, verify screw length using the gauge on the screw caddy. 9

10 Step 6 Use the MAXLOCK EXTREME HEXSTAR driver to insert the desired screw. Verify proper screw trajectory and length under fluoroscopy. Step 7 Repeat Steps 2 6 for the remaining distal screw. Step 8 Remove any temporary fixation. Attach the appropriate offset drill guide tip to the drill guide handle. Keeping the drill guide perpendicular to the surface of the plate, drill through the guide using the corresponding drill bit. Note: This technique shows preparation for a 4.0 mm non-locking screw using the 2.7 mm offset drill guide tip and 2.7 mm drill bit in the neutral orientation. Only non-locking screws may be used in the compression slot. If compression has already been achieved using the lag screw technique distally, position the guide in the compression slot in a neutral orientation (arrows opposed), as shown in Figure A. If the compression slot will be used to compress across the fracture, position the guide in the compression orientation (arrows pointing in same direction), as shown in Figure B. Figure A: Neutral Orientation 10 Figure B: Compression Orientation

11 Step 9 Determine the screw length using the provided depth gauge. Step 10 Select the appropriate length 4.0 mm nonlocking screw and insert using the MAXLOCK EXTREME HEXSTAR driver. Step 11 Drill and insert the remaining screws as needed for desired fixation. Verify correct placement of final fixation under fluoroscopy. Note: Do not over-torque the screws. Driver or implant damage may occur. Step 12 Close soft tissues as required by the operative procedure and surgeon s preferred technique. 11

12 Ordering Information Implants and Instruments PLATES Description Part # Short Left Plate Short Right Plate Medium Left Plate Medium Right Plate Long Left Plate Long Right Plate DTX-002-MSL DTX-002-MSR DTX-002-MML DTX-002-MMR DTX-002-MLL DTX-002-MLR Medial Malleolus Plate DTX-002-MAL Olive Wire MFT-040 ø1.1 mm K-Wire MFT SS 12

13 SCREWS 2.7 mm Non-Locking Screws Description Part # ø2.7 8 mm Non-locking Screw MFT ø mm Non-locking Screw MFT ø mm Non-locking Screw MFT ø mm Non-locking Screw MFT ø mm Non-locking Screw MFT ø mm Non-locking Screw MFT ø mm Non-locking Screw MFT ø mm Non-locking Screw MFT ø mm Non-locking Screw MFT ø mm Non-locking Screw MFT ø mm Non-locking Screw MFT ø mm Non-locking Screw MFT mm Non-Locking Screws Description Part # ø3.5 8 mm Non-locking Screw MFT ø mm Non-locking Screw MFT ø mm Non-locking Screw MFT ø mm Non-locking Screw MFT ø mm Non-locking Screw MFT ø mm Non-locking Screw MFT ø mm Non-locking Screw MFT ø mm Non-locking Screw MFT ø mm Non-locking Screw MFT ø mm Non-locking Screw MFT ø mm Non-locking Screw MFT ø mm Non-locking Screw MFT ø mm Non-locking Screw MFT ø mm Non-locking Screw MFT ø mm Non-locking Screw MFT ø mm Non-locking Screw MFT ø mm Non-locking Screw MFT ø mm Non-locking Screw MFT ø mm Non-locking Screw MFT ø mm Non-locking Screw MFT

14 SCREWS 3.5 mm Fixed Angle Locking Screws Description Part # ø3.5 8 mm Fixed Angle Locking Screw MFT ø mm Fixed Angle Locking Screw MFT ø mm Fixed Angle Locking Screw MFT ø mm Fixed Angle Locking Screw MFT ø mm Fixed Angle Locking Screw MFT ø mm Fixed Angle Locking Screw MFT ø mm Fixed Angle Locking Screw MFT ø mm Fixed Angle Locking Screw MFT ø mm Fixed Angle Locking Screw MFT ø mm Fixed Angle Locking Screw MFT ø mm Fixed Angle Locking Screw MFT ø mm Fixed Angle Locking Screw MFT ø mm Fixed Angle Locking Screw MFT ø mm Fixed Angle Locking Screw MFT ø mm Fixed Angle Locking Screw MFT ø mm Fixed Angle Locking Screw MFT ø mm Fixed Angle Locking Screw MFT ø mm Fixed Angle Locking Screw MFT mm Non-Locking Screws Description Part # ø4.0 8 mm Non-locking Screw MFT ø mm Non-locking Screw MFT ø mm Non-locking Screw MFT ø mm Non-locking Screw MFT ø mm Non-locking Screw MFT ø mm Non-locking Screw MFT ø mm Non-locking Screw MFT ø mm Non-locking Screw MFT ø mm Non-locking Screw MFT ø mm Non-locking Screw MFT ø mm Non-locking Screw MFT ø mm Non-locking Screw MFT ø mm Non-locking Screw MFT ø mm Non-locking Screw MFT ø mm Non-locking Screw MFT ø mm Non-locking Screw MFT ø mm Non-locking Screw MFT ø mm Non-locking Screw MFT ø mm Non-locking Screw MFT ø mm Non-locking Screw MFT ø mm Non-locking Screw MFT ø mm Non-locking Screw MFT

15 INSTRUMENTS Description Part # Plate Bending Pliers MXS-051 Bending Irons MXL mm Depth Gauge CAT ø2.4 mm Fixed Guide w/ Depth Gauge MFT FDG ø2.4 mm Keyway Drill Guide MFT KG Ratcheting Handle DRV-057 Non-Ratcheting Handle MFT-057 HEXSTAR Driver Tapered MXS-056-T ø1.9 mm Drill Bit MFT ø2.4 mm Drill Bit MFT ø2.7 mm Drill Bit MFT ø3.5 mm Lag Drill Bit MFT ø4.0 mm Lag Drill Bit MFT Drill Guide Handle MFT-171 ø1.9 mm Centered Guide Tip MFT C ø1.9 mm Offset Drill Guide Tip MFT O ø2.4 mm Centered Guide Tip MFT C ø2.4 mm Offset Drill Guide Tip MFT O ø2.7 mm Centered Guide Tip MFT C ø2.7 mm Offset Drill Guide Tip MFT O ø3.5 mm Centered Guide Tip MFT C ø4.0 mm Centered Guide Tip MFT C 15

16 1023 Cherry Road Memphis, TN Nesbitt Avenue South Bloomington, MN Trademarks and Registered marks of Wright Medical Group N.V. or its affiliates Wright Medical Group N.V. or its affiliates. All Rights Reserved. MXE Rev B ECN Apr-2016