KNOTLESS AC TIGHTROPE OPEN REPAIR IMPLAN

Description of Event or Problem

IT WAS REPORTED THAT THE TIGHROPE BECAME LOOSENED POST OPERATIVE. IT WAS FURTHER REPORTED THAT DURING THE INITIAL SURGERY ON (B)(6) 2025 THE SUTURES WERE LEFT 0.5 CM LONG AND A TEST HOOK WAS USED AS AN ABUTMENT WHEN TIGHTENING THE IMPLANT. IT WAS THEN NOTICED DURING THE CONTROL ON A MRT ON THE (B)(6) 2025 IT WAS FOUND THAT THE CLAVICULA HAS A HIGH STAND AND THE TIGHROPE BECAME LOOSENED. UPDATE DW 17-SEP-2025: FURTHER INFORMATION WAS PROVIDED THAT THE IMPLANT REMAINED INSIDE THE PATIENT, AND NO ADDITIONAL SURGERY IS PLANNED. THE USED BATCH NUMBER IS 15291445 AND IT WAS FURTHER CONFIRMED THAT THE PATIENT DID NOT FOLLOW THE POST OP GUIDANCE WHICH CAUSED THE BROKEN TIGHTROPE.

Additional Manufacturer Narrative

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