MINI MAXLOCK EXTREME™ 801-003...3 Key Design Features The MINI MAXLOCK EXTREME MTP Plates are an...

™™MINI MAXLOCK EXTREMEMTP Set

SURGIC AL TECHNIQUE

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Table of Contents

Key Design Features 3

Surgical Technique

Standard MTP Plate 4

MTP Plate with POCKETLOCK™ Technology 10

Implants and Instruments 18

Contents

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.

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Key Design Features

The MINI MAXLOCK™ EXTREME™ MTP Plates are an extension of the MINI MAXLOCK™ EXTREME™ Plate and Screw system. The low-profile plates come in a variety of options to meet surgeon preference and patient anatomy. All of the MTP plates are contoured with 10° of valgus and 5° of dorsiflexion. The standard MTP plates incorporate a compression slot which allows for 1.25 mm of translation. The MTP Plates with POCKETLOCK™ Technology provide the ability to insert a targeted 4.0 mm non-locking inter-fragmentary screw through a plate, across the MTP joint. The system offers non-locking, fixed angle locking, and variable angle locking screws to provide fixation without compromise.

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Standard Plate Technique

Step 1

Prepare the first MTP joint for fusion using the surgeon’s preferred technique. If reaming is desired to prepare the joint, reference the Wright Foot and Ankle Reamer System Surgical Technique.

During the joint preparation, care should be taken not to remove too much of the bony prominences superiorly to avoid excessive dorsiflexion of the fused joint.

Step 2

If desired, temporarily fix the joint in the desired position using the provided k-wires.

Step 3

Choose the desired MINI MAXLOCK™ EXTREME™ MTP Plate. The plates are pre-contoured to provide 10° of valgus and 5° of dorsiflexion. The plates are designated for the left or right foot, with the compression slot on the proximal bone.

Note: If desired, the compression slot can be placed on the distal bone, by using the left plate on the right foot and vice versa.

Note: The MINI MAXLOCK™ EXTREME™ implants are designed for smaller anatomies. For larger anatomies or higher load bearing applications, consider using the MTP plates from the MAXLOCK™ EXTREME™ System.

SurgicalTechnique

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Step 4

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 cross threading of the fixed angle locking screw or the Mini PEEK Ring.

Step 5

Place the plate on the bone and temporarily fix it to the bone using 0.9 mm k-wires or olive wires provided in the MINI MAXLOCK™ EXTREME™ plate caddy. The laser etched line on the plate should align with the joint line.

Step 6

Select either a non-locking, fixed angle locking, or variable angle locking MINI MAXLOCK™ EXTREME™ screw. In order to generate compression, the plate must first be fixed with at least two screws on the opposite side of the fusion than the compression slot using non-locking or fixed angle locking screws. The locking screw holes in the plate are compatible with a variety of screw options. In the locking threaded holes, MINI MAXLOCK™ EXTREME™ non-locking 2.0 mm (silver), 2.4 mm (green) or 2.7 mm (magenta) screws, fixed angle locking 2.4 mm (green) or 2.7 mm (magenta) screws, and 2.4 mm (blue) variable angle locking screws (optional) can be used. Depending on surgeon preference and indication, a combination of the MINI MAXLOCK™ EXTREME™ screws can be used.

Note: Sets are configured to contain either 2.0 mm and 2.4 mm or 2.4 mm and 2.7 mm screws. For the MTP plate, we recommend using the 2.4 mm or 2.7 mm screws.

WARNING: Do not use any other manufacturers’ screws with these implants.

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Step 7

Based on the screw selection, choose the appropriate drill bit. Color-coded drill bits that correspond with the screws are provided in the system: 1.3 mm (silver), 1.6 mm (green and blue), 1.9 mm (magenta), 2.4 mm (double green) and 2.7 mm (double magenta). The 1.3 mm drill bit is to be used in conjunction with 2.0 mm non-locking screws; the 1.6 mm drill bit is to be used in conjunction with 2.4 mm non-locking, fixed angle locking, and variable angle locking screws; the 1.9 mm drill bit is to be used in conjunction with the 2.7 mm non-locking and fixed angle locking screws; the 2.4 mm drill bit is to be used to over drill for the lag technique with 2.0 mm and 2.4 mm screws; and the 2.7 mm drill bit is to be used to over drill for the lag technique with the 2.0 mm, 2.4 mm and 2.7 mm screws.

Step 8

Several drill guides are offered in the system and are color-coded to match the corresponding drill bit and screw diameter. When drilling for non-locking screws the centered drill guide tips should be used. When drilling for fixed angle locking screws, the threaded guides should be used. For variable angle locking screws, the cone drill guide should be used. When a lag technique is desired, use a double banded drill bit and double banded drill guide tip to over drill the gliding hole. Offset drill guide tips are provided for drilling the pilot hole in the compression slot. See Steps 15–17 for compression slot technique.

Select the appropriate drill guide and drill to the desired depth. Take care not to move the plate after drilling for a locking hole in order to maintain proper pilot hole alignment and prevent fixed angle locking screw cross threading.

Note: Do not under drill for the screws.

Note: To use the drill guide tips, insert the desired guide head into the handle with the guide hole turned out.

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Step 9

Determine the screw length required using the provided depth gauges. In the 2.0 mm / 2.4 mm set configuration, two depth gauges are included in the set. They are color-coded to match the drill bit.

Step 10

(Optional) For the variable angle locking technique, prior to inserting the screw, insert the Mini PEEK Ring, made from PEEK-OPTIMA® polymer by Invibio, into the plate. Drive the Mini PEEK Ring until the ring shoulder stops at the top surface of the plate and the driver pops out of the Mini PEEK Ring. The Mini PEEK Ring driver is single use only and should be disposed of.

Step 11

Remove the desired screw from the screw caddy using the corresponding HEXSTAR™ driver. For non-locking and fixed angle locking screws, use the self-retaining tapered driver. For variable angle locking screws, use the blue banded driver. For all screws used throughout the procedure, verify the screw length using the appropriate gauge on the screw caddy.

Note: Do not drill through the Mini PEEK Ring. Drill and measure the length prior to inserting the Mini PEEK Ring into the plate.

Note: An optional self-retaining sleeve is available upon request for the variable angle locking driver.

Note: The depth gauge reading corresponds to the working length of the screw (from the distal tip to underneath the screw head).

WARNING: Place all non-locking screws (including the one in the compression slot) before using variable angle locking screws.

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Step 12

With the HEXSTAR™ driver, insert the selected screw into the hole and drive the screw. Do not fully tighten the screw to the plate.

For variable angle locking screws, stop driving the screw when the bottom of the head hits the top surface of the Mini PEEK Ring.

Step 13

For the variable angle locking screws, use the depth-limiting driver to fully seat the screws. Using the depth limiting driver, drive the screw normal to the top surface of the Mini PEEK Ring until the driver disengages. The highest point of the screw should sit flush with the top surface of the Mini PEEK Ring.

Step 14

Repeat Steps 6–13 until at least two of the locking screw holes on the opposite side of the joint as the compression slot are filled. At least one of the screws should be a fixed angle locking screw. Fully tighten the screws on the opposite side of the compression slot.

Step 15

For the compression slot, select the appropriate drill bit and offset drill guide tip for the desired non-locking screw size. Insert the offset drill guide into the compression slot with the arrow on the drill guide oriented in the same direction as the arrow on the plate. Insert the appropriate drill bit through the drill guide and drill to the desired depth. The hole may go through one or both of the cortices.

Correct driver alignment Incorrect driver alignment

Note: Do not drive the screws too deep. Only drive the screw until the highest point of the screw is flush with the top of the Mini PEEK Ring. Do not use power instruments with the depth limiting driver.

Note: Only non-locking screws may be used in the compression slot.

WARNING: The variable angle screws may only be inserted into the Mini PEEK Ring once before it must be discarded.

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Step 16

Determine the screw length required using the provided depth gauge, and remove any temporary fixation.

Step 17

Remove the screw from the caddy using the HEXSTAR™ driver and insert the screw into the hole. Drive the screw into the plate until it is fully seated in order to generate compression.

Step 18

Repeat Steps 6–13 to fill all remaining locking holes as desired with MINI MAXLOCK™ EXTREME™ screws.

Step 19

Completely tighten all remaining screws. During final tightening, take caution to not over torque the screws.

Step 20

Verify the correct placement of the plate and screws.

Step 21

Replace the soft tissues as required by the operative procedure and surgeon preferred technique.

Special Note: For removal of the Mini PEEK Ring, use the provided mini ring removal tool. After removing the screw, insert the mini ring removal tool into the Mini PEEK Ring and rotate counter-clockwise. The Mini PEEK Ring is no longer usable and should be disposed of.

Start Position Finish Position

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Alpha Plate on a Left Foot with Pocket on Distal Bone

POCKETLOCK™ Plate Technique

Step 1

Prepare the first MTP joint for fusion using the surgeon’s preferred technique. If reaming is desired to prepare the joint, reference the Wright Foot and Ankle Reamer System Surgical Technique.

During the joint preparation, care should be taken not to remove too much of the bony prominences superiorly to avoid excessive dorsiflexion of the fused joint.

Note: The MINI MAXLOCK™ EXTREME™ implants are designed for smaller anatomies. For larger anatomies or higher load bearing applications, consider using the MTP plates from the MAXLOCK™ EXTREME™ System.

Step 3

Choose the desired MINI MAXLOCK™ EXTREME™ MTP Plate with POCKETLOCK™ Technology. The plates are pre-contoured to provide 10° of valgus and 5° of dorsiflexion. The plates can be used on either foot. The plates should be placed so that the pocket on the bottom surface of the plate is on the medial side of the foot. For instance, using the Alpha plate on the right foot the pocket is on the proximal side of the joint. When used on the left foot, the pocket of the Alpha plate is on the distal side of the joint.

Step 2

Temporarily fix the joint in the desired orientation by placing a k-wire obliquely through the plantar half of the bones from medial to lateral across the joint.

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Step 4

Assemble the plate template that corresponds to the chosen plate with the countersink guide by snapping the template into the guide. Lay the template on the bone and orient to the desired position of the plate. The laser etched line on the template shows where the plate bends to introduce dorsiflexion. The laser etched line should be entirely on the opposite side of the joint line as the pocket. Place two 0.9 mm k-wires normal to the template in the k-wire holes to prevent the template from rotating. Do not bend the wires.

Step 5

Select the provided countersink and drill through the template assembly to prepare for the plate pocket and inter-fragmentary screw. Insert the countersink until the shoulder of the countersink hits the guide.

WARNING: Do not use power instruments with the countersink.

Step 6

With the k-wires still in place, slide the template off the bone. Then, using the wires to help locate, slide the chosen plate over the k-wires. The plate’s pocket should fit within the prepared hole and the solid laser etched line on the plate should be on the opposite side of the joint line as the pocket.

Step 7

If necessary, use the 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 cross threading of the fixed angle locking screw or the Mini PEEK Ring.

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Step 8

Select a MINI MAXLOCK™ EXTREME™ screw to be used in one of the threaded locking holes that is on the same side of the joint, proximally or distally, as the pocket. The screw holes in the plate are compatible with a variety of screw options. In the locking threaded holes, MINI MAXLOCK™ EXTREME™ non-locking 2.0 mm (silver) 2.4 mm (green) or 2.7 mm (magenta) screws, fixed angle locking 2.4 mm (green) or 2.7 mm (magenta) screws, and 2.4 mm (blue) variable angle locking screws (optional) can be used.

Depending on surgeon preference and indication, a combination of the MINI MAXLOCK™ EXTREME™ screws can be used.

Step 9

Based on the screw selection, choose the appropriate drill bit. Color-coded drill bits that correspond with the screws are provided in the system: 1.3 mm (silver), 1.6 mm (green and blue), 1.9 mm (magenta), 2.4 mm (double green) and 2.7 mm (double magenta). The 1.3 mm drill bit is to be used in conjunction with 2.0 mm non-locking screws; the 1.6 mm drill bit is to be used in conjunction with 2.4 mm non-locking, fixed angle locking, and variable angle locking screws; the 1.9 mm drill bit is to be used in conjunction with the 2.7 mm non-locking and fixed angle locking screws; the 2.4 mm drill bit is to be used to over drill for the lag technique with 2.0 mm and 2.4 mm screws; and the 2.7 mm drill bit is to be used to over drill for the lag technique with the 2.0 mm, 2.4 mm and 2.7 mm screws.

Note: Do not under drill for the screws.

Note: Sets are configured to contain 2.0 mm and 2.4 mm screws or 2.4 mm and 2.7 mm screws. For the MTP plate, we recommend using the 2.4 mm or 2.7 mm screws.

WARNING: Do not use any other manufacturer’s screws with these implants.

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Step 10

Several drill guides are offered in the system and are color-coded to match the corresponding drill bit and screw diameter. When drilling for non-locking screws the centered drill guide tips should be used. When drilling for fixed angle locking screws, the threaded guides should be used. For variable angle locking screws, the cone drill guide should be used. When a lag technique is desired, use a double banded drill bit and double banded drill guide tip to over drill the gliding hole.

Select the appropriate drill guide and drill to the desired depth. Take care not to move the plate after drilling for a locking hole in order to maintain proper pilot hole alignment and prevent fixed angle locking screw cross threading.

Step 11

Determine the screw length required using the provided depth gauges. In the 2.0 mm / 2.4 mm set configuration, two depth gauges are included in the set. They are color-coded to match the drill bits.

Step 12

(Optional) For the variable angle locking screws, prior to inserting the screw, insert the Mini PEEK Ring, made from PEEK-OPTIMA® polymer by Invibio, into the plate. Drive the Mini PEEK Ring until the ring shoulder stops at the top surface of the plate and the driver pops out of the Mini PEEK Ring. The Mini PEEK Ring driver is single use only and should be disposed of.

Note: Do not drill through the Mini PEEK Ring. Drill and measure the length prior to inserting the Mini PEEK Ring into the plate.

Note: The depth gauge reading corresponds to the working length of the screw (from the distal tip to underneath the screw head).

Note: To use the drill guide tips, insert the desired guide head into the handle with the guide hole turned out.

WARNING: Place all MINI MAXLOCK™ EXTREME™ non-locking screws before using variable angle locking screws.

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Step 13

Remove the desired screw from the screw caddy using the corresponding HEXSTAR™ driver. For non-locking and fixed angle locking screws, use the self-retaining tapered driver. For variable angle locking screws, use the blue banded driver. For all screws used throughout the procedure, verify the screw length using the appropriate gauge on the screw caddy.

Step 14

With the HEXSTAR™ driver, insert the selected screw into the hole and drive the screw. Do not fully tighten the screw to the plate.

For variable angle locking screws, stop driving the screw when the bottom of the head hits the top surface of the Mini PEEK Ring.

Step 15

For the variable angle locking screws, use the depth-limiting driver to fully seat the screws. Using the depth limiting driver, drive the screw normal to the top surface of the Mini PEEK Ring until the driver disengages. The highest point of the screw should sit flush with the top surface of the Mini PEEK Ring.

Step 16

Repeat Steps 8-15 until at least two of the locking screw holes that are on the same side of the joint as the pocket are filled. Fully tighten the screws on the same side as the pocket.

Note: Do not drive the screws too deep. Only drive the screw until the highest point of the screw is flush with the top of the Mini PEEK Ring. Do not use power instruments with the depth limiting driver.

Note: An optional self-retaining sleeve is available upon request for the variable angle locking driver.

WARNING: The variable angle screws may only be inserted into the Mini PEEK Ring once before it must be discarded.

Correct driver alignment Incorrect driver alignment

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Step 17

Select the 1.4 mm guide wire tip and insert the tip into the handle with the guide hole turned out. Using the 1.4 mm guide wire tip, insert a 1.4 mm guide wire in to the pocket hole across the MTP joint. Ensure that the guide tip is seated within the pocket before inserting the wire. The dashed laser etched line on the plate can be used as reference for the trajectory of the pocket hole.

Step 18

Determine the screw length required over the guide wire using the depth gauge provided in the MTP caddy.

Step 19

Use the 2.7 mm cannulated drill bit to drill for the inter-fragmentary pocket screw over the guide wire. Remove the pocket guide wire after drilling. The k-wires providing temporary fixation and alignment should remain in place.

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Step 20

With the HEXSTAR™ driver provided in the MTP caddy for the 4.0 mm MAXLOCK™ EXTREME™ screws (teal), remove the desired 4.0 mm screw from the caddy and verify its length on the gauge on the caddy.

Step 21

Insert the inter-fragmentary screw into the pocket of the plate using the corresponding HEXSTAR™ driver. With the temporary fixation wires still in place, insert the pocket screw until it is provisionally tight. Then, remove the wires and fully tighten the pocket screw.

WARNING: Do not overtighten the pocket screw as this may result in misalignment of the joint.

Note: Only 4.0 mm non-locking screws can be used in the pocket of the plate. Partially threaded, solid 4.0 mm non-locking MAXLOCK™ EXTREME™ screws are provided in the set. If a fully threaded screw is desired for the interfragmentary screw, the fully threaded solid 4.0 mm non-locking MAXLOCK™ EXTREME™ screws are available on request. With this screw selection, the countersink with lag feature should be used in Step 5 to allow for compression to be generated across the fusion site. If a cannulated screw is desired for interfragmentary screw, the 4.0 mm MAXTORQUE™ screws are available upon request. With this screw selection, the MAXTORQUE™ driver should be used for insertion.

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Special Note: For removal of the Mini PEEK Ring, use the provided mini ring removal tool. After removing the screw, insert the mini ring removal tool into the Mini PEEK Ring and rotate counter-clockwise. The Mini PEEK Ring is no longer usable and should be disposed of.

Step 22

Repeat Steps 8–15 to fill all remaining locking holes with MINI MAXLOCK™ EXTREME™ screws.

Step 23

Completely tighten all remaining screws. During final tightening, take caution to not over torque the screws.

Step 24

Verify the correct placement of the plate and screws.

Step 25

Replace the soft tissues as required by the operative procedure and surgeon preferred technique.

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Implants and Instruments

PLATES

Description Part #

Standard Left Plate MXM-002-MTP-L

Standard Right Plate MXM-002-MTP-R

POCKETLOCK™ Alpha Plate MXM-002-MTP-PA

POCKETLOCK™ Beta Plate MXM-002-MTP-PB

ø1.4 mm POCKETLOCK™ Guide Wire MXM-040-14-MTP

MTP POCKETLOCK™ Depth Gauge MXM-059-MTP

Pocket Countersink MXM-074-MTP-S

ø1.4 mm POCKETLOCK™ Drill Guide Tip MXM-171-14-MTP

Pocket Countersink Guide MXM-175-MTP

POCKETLOCK™ Template – Alpha MXM-175-MTP-PA

POCKETLOCK™ Template – Beta MXM-175-MTP-PB

ø2.7 mm Drill Bit CSS-072-27

HEXSTAR™ Driver-Tapered MXS-056T

ø0.9 mm K-Wire MXM-040-09

Optional

ø2.4 mm Ring/Driver Assm. VAR-032-24

ø2.4 mm Depth Limiting Driver VAR-056-24

ø2.4 mm Variable Drill Guide VAR-171-24-R

HEXSTAR™ Driver VAR-056-24H

ø1.6 mm Variable Drill Guide VAR-071-16-F

ø2.4 mm Ring Removal Tool VAR-156-24

ø2.4 mm Variable Driver Self Retaining Sleeve

VAR-056-24-SR

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SCREWS

2.4 mm Mini Non-Locking Screws

Description Part #

ø2.4 × 6 mm Non-locking Screw MXM-011-24-06















2.7 mm Mini Non-locking Screws

Description Part #
















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SCREWS

4.0 mm MAXLOCK™ EXTREME™ Partially Threaded Non-Locking Screws

Description Part #

ø4.0 × 16 mm Partially Threaded Screw MFT-011-40P-16








ø4.0 × 32.5 mm Partially Threaded ScrewMFT-011-40P-325

2.4 mm Mini Fixed Locking Screws

Description Part #

ø2.4 × 6 mm Fixed Locking Screw MXM-021-24-06















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SCREWS

2.7 mm Mini Fixed Locking Screws

Description Part #
















2.4 mm Mini Variable Angle Screws

Description Part #

ø2.4 × 6 mm Variable Angle Screws VAR-031-24-06













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INSTRUMENTS

Description Part #

ø1.6 mm Drill Bit MXM-072-16

ø1.9 mm Drill Bit MXM-072-19

ø2.7 mm Lag Drill Bit MXM-072-27

Ratcheting Handle HCS-057

Non-Ratcheting Handle HCS-058

Drill Guide Handle MFT-171

HEXSTAR™ Driver MXM-056T

HEXSTAR™ Driver – Break Away MXM-056BA

50 mm Depth Gauge MXM-059-50

Plate Forceps MXM-060

Stagbeetle Forceps MXM-062

Bone Hook MXM-063

Periosteal Elevator MXM-068

ø1.6 mm Fixed Drill Guide MXM-071-16-F

ø1.9 mm Fixed Drill Guide MXM-071-19-F

ø1.6 mm Centered Drill Guide MXM-171-16-C

ø1.6 mm Offset Drill Guide MXM-171-16-O

ø1.9 mm Centered Drill Guide MXM-171-19-C

ø1.9 mm Offset Drill Guide MXM-171-19-O

ø2.7 mm Lag Guide Tip MXM-171-27-C

Plate Bending Pliers MXS-051

Baby Hohmann MXS-067

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Notes

™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.

MXM 801-003 Rev A ECN 160492 13-Apr-2016

1023 Cherry RoadMemphis, TN 38117800 238 7117901 867 9971www.wright.com

10801 Nesbitt Avenue SouthBloomington, MN 55437888 867 6437952 426 7600www.tornier-us.com

MINI MAXLOCK EXTREME™ 801-003...3 Key Design Features The MINI MAXLOCK EXTREME MTP Plates are an...

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