KNOTLESS T-ROPE SYN-DESMOSIS REPR TI

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: B5, G3, H3, H6. THE COMPLAINT DEVICE WAS NOT RECEIVED FOR EVALUATION. BASED ON THE INFORMATION PROVIDED, WHICH MAY INCLUDE THE RETURNED DEVICE (IF AVAILABLE), PICTURES, VIDEOS, EVENT DESCRIPTIONS, AND ANY ADDITIONAL FIELD DATA, ARTHREX CONCLUDED THE MOST LIKELY CAUSE OF THE REPORTED FAILURE. THE MOST LIKELY CAUSE OF THE REPORTED FAILURE IS USER ERROR, SPECIFICALLY IMPROPER BONE PREPARATION, EXCESSIVE FORCE, AND/OR INCORRECT SURGICAL TECHNIQUE. THE COMPLAINT ALLEGATION WAS CONFIRMED FOLLOWING EVALUATION OF THE ATTACHED CUSTOMER-PROVIDED IMAGE, WHICH SHOWED THAT THE SUTURES WERE BROKEN AND FRAYED. A SUTURE BUNCH WAS ALSO OBSERVED, WHICH MAY INDICATE IMPROPER SURGICAL TECHNIQUE.

Description of Event or Problem

ADDITIONAL INFORMATION: THE CASE WAS COMPLETED USING ANOTHER AR-8926T KNOTLESS TIGHTROPE SYNDESMOSIS REPAIR IMPLANT. THE EVENT OCCURRED DURING THE INSERTION PROCESS, PRIOR TO THE IMPLANT BEING FULLY PLACED OR TRACTION BEING APPLIED. THE SURGERY WAS NOT DELAYED, AND NO ADDITIONAL ANESTHESIA WAS ADMINISTERED TO THE PATIENT. ALL DETACHED FRAGMENTS, INCLUDING BUTTONS AND SUTURES, WERE ACCOUNTED FOR AND RETRIEVED DURING THE PROCEDURE. NO ADVERSE EFFECTS WERE REPORTED DURING OR FOLLOWING THE PROCEDURE AS A RESULT OF THIS ISSUE.

Additional Manufacturer Narrative

INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED UPON AVAILABILITY OF ADDITIONAL INFORMATION.

Description of Event or Problem

ON 10/15/2025, AN ARTHREX SUBSIDIARY EMPLOYEE REPORTED VIA EMAIL THAT AN AR-8926T KNOTLESS TIGHTROPE SYNDESMOSIS REPAIR IMPLANT BROKE WHEN TRACTION WAS APPLIED DURING INJURY REDUCTION. AS A RESULT, A SECOND DEVICE WAS REQUIRED TO COMPLETE THE PROCEDURE. ALL BROKEN PIECES WERE RETRIEVED FROM THE PATIENT. THIS OCCURRED DURING AN OPEN REDUCTION AND INTERNAL FIXATION (ORIF) OF ANKLE SYNDESMOSIS PERFORMED ON (B)(6) 2025. ADDITIONAL INFORMATION HAS BEEN REQUESTED ON 10/20/2025.