SYNDESMOSIS TIGHTROPE PRO IMPLANT, SS

Description of Event or Problem

ON 28-MAY-2026, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT TWO AR-9925SS SYNDESMOSIS TIGHTROPE PRO DEVICES EXPERIENCED AN ISSUE IN WHICH, DURING INSERTION, THE BUTTONS DETACHED FROM THE INSERTER WITH LITTLE TO NO RESISTANCE. THE EVENTS WERE DISCOVERED DURING AN ANKLE ORIF PROCEDURE PERFORMED ON (B)(6) 2026. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PIECES BROKE OFF INSIDE THE PATIENT. ADDITIONAL INFORMATION WAS RECEIVED ON 03-JUN-2026: THE ANCHOR WAS REMOVED, AND NO COMPONENTS REMAINED IN THE PATIENT. NO DEVICE BREAKAGE OCCURRED WITHIN THE PATIENT. AN X-RAY WAS PERFORMED TO CONFIRM THAT NO FRAGMENTS WERE RETAINED. THE PROCEDURE WAS COMPLETED USING AN AR-8925SS TIGHTROPE XP, WHICH FUNCTIONED AS INTENDED. THE CASE EXPERIENCED AN APPROXIMATE 15-MINUTE DELAY WHILE TROUBLESHOOTING THE INITIAL SYSTEM. IT IS UNKNOWN WHETHER ADDITIONAL ANESTHESIA WAS ADMINISTERED.

Additional Manufacturer Narrative

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