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Sean Scanlan

From: Sean ScanlanSent: Sunday, October 09, 2016 11:53 PMTo: ISA Principal's; ISA Associate'sSubject: Important Lapiplasty UpdatesAttachments: Pre-Case Lapiplasty Review.pdf; What Do I Need for a Lapiplasty Case 10-6-2016.pdf

Sales Agents,  I wanted to reach out with several important updates regarding the Lapiplasty™ System.  There are 3 updates that are addressed below.  

1.  Pre‐Case Lapiplasty Review Document We are releasing a “Pre‐Case Lapiplasty Review” document for both our sales team and to send to our Lapiplasty surgeons as they prep for cases.  This document has links to the full surgical technique (written & video), but more importantly it contains the latest essential steps and “pearls” that we have found to be absolutely critical for achieving a great end result.  Please review to familiarize yourself with the info and also make sure that it’s sent to all surgeons with upcoming  cases. 2. What Do I Need for a Lapiplasty Case See the attached “What Do I Need for a Lapiplasty Case” document as a reference for what you need to order/bring in for a Lapiplasty case.  We have had several cases where essential product was missing in the case, so please review. 3. New Control 360™ Packaging We have released our new branded SK12 Control 360 Packaging (will replace the white “pizza box” cartons) – see image in “What Do I need for a Lapiplasty Case” document.  Please continue to use any existing Control 360 inventory that you have, but this will be shipped out on all orders moving forward.  In addition to the updated branding on the packaging, there are also some important updates to the kit contents that you need to become familiar with: 

Screw Drivers ‐ There are 2 of the large handle drivers sterile inside the kit (the ones that we have been sending out non‐sterile) 

Long Screw ‐ There is a new 32mm (Blue) M1‐M2 screw (in addition to the 28mm Gold), so you now have a longer option. Our 2mm drill bit has 2 marks on it, drill to 2nd if using the blue 32mm screw. 

2.5 Drill Bit ‐ There is a new 2.5mm drill bit (Gold Ti nitride color) to use as either a) sturdier drill for fenestration, b) overdrill to use if you want/need to “lag” the M1/M2 screw. 

0.62 K‐wires – There is an 0.62 K‐wire added to the kit, used for 1) less invasive stabilizing wire to insert through Positioner, 2) use in MTP fusion cases (provisional fixation, or for reamers). 

Plate Benders ‐ The plate benders in this kit now have a “rescue hex” feature on the end of the handle to remove drill guides if they are “stuck” on the plate.   

Please let me know if you have any questions about the above.  We’re looking forward to seeing more great Lapiplasty cases rolling in as we ramp up for “Bunion Season” at the end of the year!   Thank you, Sean   Sean Scanlan, PhD 

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Director of Marketing 

   Email: sscanlan@treace.net Mailing Address: Office: 904.373.5940 Ext. 307 3107 Sawgrass Village Circle Mobile: 650.387.9802 Ponte Vedra Beach, FL 32082 Fax: 904.834.7169  www.treace.com   

Pre-Case Lapiplasty™ Procedure Review Updated 10-9-2016

In preparation for your upcoming Lapiplasty™ case, we would like to share the following resources to help facilitate your review and preparation process. Additionally, the Lapiplasty™ designing surgeons are available to review your pre-op X-rays and/or answer any questions that you may have – please let us know if you would like to contact them.

Surgical Technique Guides: Lapiplasty™ Procedure Detailed Written Surgical Technique PDF: http://www.treace.com/wp-content/uploads/2016/05/Lapiplasty-Surgical-Technique-M010-Rev-A.pdf Lapiplasty™ Procedure Surgical Video Video demonstration: https://vimeo.com/166074241

Critical Steps & Pearls for a Successful Case: Dorsal Incision – Just Medial to EHL It is critical that the 1st TMT incision is made direct dorsal, just medial to the EHL tendon. A medially-biased incision will not allow the proper positioning of the Cut Guide or the Fulcrum. Conservative Lateral Release (when necessary) The MTP joint must be fully mobilized to achieve the desired three-plane correction. If the MTP joint is stiff and/or the sesamoids are ankylosed, perform a conservative “stab” or mini-open lateral release of the lateral capsule and sesamoid suspensory ligaments prior to applying the Positioner. Manually manipulate the MTP joint to release the lateral capsule. As a general rule of thumb, patients over the age of 40 yrs tend to require a lateral release (in most cases). “Mini-Open” video demonstration: https://vimeo.com/186015107 “Stab” video demonstration: https://vimeo.com/185747884

Aggressive 1st TMT Release Complete mobilization of the 1st TMT joint (i.e. basically detaching the MT from the cuneiform) is critical to achieve an anatomic three-plane correction without getting “springback” later in the case. After planing the TMT joint with the saw (be sure to plane off both lateral and medial plantar flares of the MT, so it will glide against the cuneiform w/o distracting the joint when rotating), perform a progressive release of the capsule and plantar ligaments using a ¼ inch osteotome in a “pie-crusting” motion (get the “celery crunch” sound) to make sure all the plantar-medial and plantar-lateral aspects of the soft-tissue attachments are fully released. Then, perform a “trial reduction” – check on fluroro that the MT can be fully rotated (with the joystick pin) and the IM reduced with minimal manual pressure at the MT head (see image below). Until this “trial reduction” can be demonstrated on flouro, DO NOT use the Positioner. Video demonstration: https://vimeo.com/161981702 Proximal Fulcrum Position The Fulcrum must be positioned with its proximal edge at the level of the TMT joint, secured against the apex of the 1st MT lateral flare. Placement and maintenance of the Fulcrum at this proximal location is critical as it acts both as a pivot point and a spacer when applying the Positioner.

Fluoro showing MT rotation with joystick pin and

IM reduction with manual pressure; a VITAL step

to perform before using the Positioner.

Check Cut Guide Alignment Take a fluoro looking “down the gun sight” of the Cut Guide to confirm its alignment. When aligned properly, the Cut Guide should point down the middle of the long axis of the MT setting up a flat & even cut off the base of the MT and a wedge off the cuneiform that’s perpendicular (or slightly negatively-angled) to the long axis of the foot. If the Cut Guide is taking a wedge off the base of the MT (see right image below), use index finger to press MT tip of guide more medially while pinning to correct its alignment and set up a flat & even cut off MT base. NOTE: Pushing with too much force on tip of guide to correct can “pry open” the joint and affect cut alignment.

Add “Extra” Rotation Prior to Compression Olives After fenestrating the cut bone surfaces (10-12 holes per side), rotate the MT pin past parallel relative to the cuneiform pin to add ~15° of extra rotation before compressing with the threaded olive wires. The “extra” rotation accounts for rotation that can be lost when the tissues relax after removing the Positioner. Note that the olive wire should be angled from the lateral aspect of the MT to ensure that the lateral side of the TMT joint is compressed to close down the IM angle. NOTE: When performed correctly, the MT pin should maintain the over-rotated position after compression. If the pin slides back to parallel, back out the olive and consider another olive throw.

What Do I Need for a Lapiplasty™ Case?

2 x SK12 Control 360™ (one as backup)

1 x SD11 Plantar Python™ Plate - Left

1 x SD12 Plantar Python™ Plate - Right

Below represents the minimum quantities of product that should be brought in per Lapiplasty™ case you are covering. Due to the sterile-packed nature of TMC products, it is encouraged to have additional backup product available (beyond the minimum) when feasible.

1 x Lapiplasty™ Instrument Tray2 x Positioners (1405-2036)

2 x Joint Seekers (1405-2070)

2 x Fulcrums (1405-XXXX)

1 x 5.0° Cut Guide (1405-2081)

1 x 7.5° Cut Guide (1405-2084)

2 x Screw Drivers (1405-2104) – as backup

1 x SM-4011 40mm Lapiplasty™ Saw Blade (Stryker)

1 x ZMS-4011 40mm Lapiplasty™ Saw Blade (Linvatec)

SM-4011 ZMS-4011

Additional Items (per surgeon request)1 x SM-3225 Lapiplasty™ 31mm Saw Blade (Stryker)

Designed for Release & Planing of 1st TMT joint

1 x ZMS-3109 Lapiplasty™ 31mm Saw Blade (Linvatec)

Designed for Release & Planing of 1st TMT joint Updated 10-5-2016