K-LESS T-ROPE W/DRV, SYN REPR, SS

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 29-MAY-2026, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA EMAIL THAT A SYNDESMOSIS TIGHTROPE XP EXPERIENCED AN ISSUE DURING USE. THE SPECIALIST INSERTED THE GUIDE PIN FROM THE KIT, ADVANCED THE CANNULATED DRILL BIT OVER THE PIN, THEN REMOVED THE DRILL BIT WHILE MAINTAINING THE PIN IN THE CHANNEL. THE TIGHTROPE WAS THEN INSERTED, AND IMPLANT POSITION WAS VERIFIED VIA X-RAY. THE RED LOCK WAS CONFIRMED TO BE PROPERLY ALIGNED, THE LOCK WAS REMOVED, AND THE BLACK BUTTON WAS PRESSED TO DEPLOY THE PLATE. POSITION WAS AGAIN VERIFIED VIA X-RAY AS THE SYSTEM WAS BEING CLOSED. UPON FURTHER CHECKS, IT WAS OBSERVED THAT THE PLATE HAD RETRACTED. AN ATTEMPT TO REPOSITION THE PLATE WAS UNSUCCESSFUL, AND A NEW KIT WAS REQUESTED AND IMPLANTED IN THE PATIENT. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2026. ADDITIONAL INFORMATION WAS RECEIVED ON 02-JUN-2026: THIS OCCURRED DURING A SYNDESMOSIS PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW PLATE FROM A REPLACEMENT AR-8925SS SYNDESMOSIS TIGHTROPE. NO DEVICE BREAKAGE OCCURRED WITHIN THE PATIENT, AND NO FRAGMENTS WERE RETAINED.