KNOTLESS AC TIGHTROPE OPEN REPAIR IMPLAN

Additional Manufacturer Narrative

COMPLAINT ALLEGATION IS CONFIRMED. VISUAL INSPECTION, REVEALS THAT THE EDGES AROUND THE THREADED AREA OF THE BUTTON WERE CHIPPED/DAMAGED. THREADS AT THE DISTAL END OF THE SHAFT WERE STRIPPED. THE BUTTON WAS RETURNED DISASSEMBLED FROM THE SHAFT. FUNCTIONAL TESTING WAS NOT PERFORMED DUE TO THE DAMAGE TO THE DEVICE. PER SURGICAL TECHNIQUE - LT1-000162-EN - 1-THROUGH AN OPEN OR MINI-OPEN INCISION, DRILL A 3.7 MM TUNNEL THROUGH BOTH THE CLAVICLE AND CORACOID. FLUOROSCOPY CAN BE USED TO CONFIRM PROPER TUNNEL PLACEMENT. THE METHOD OF BONE PREPARATION AND THE QUALITY OF THE BONE ENCOUNTERED WERE NOT SPECIFIED. THE MOST LIKELY CAUSE OF THE REPORTED FAILURE IS ATTRIBUTED TO USER ERROR RESULTING FROM IMPROPER SURGICAL TECHNIQUE. CONTRIBUTING FACTORS MAY INCLUDE INADEQUATE BONE PREPARATION, MISALIGNMENT/PRYING OR LEVERAGING OF THE DEVICE DURING INSERTION, WHICH COULD LEAD TO THE BUTTON SEPARATING OR DISENGAGED FROM THE SHAFT.

Additional Manufacturer Narrative

COMPLAINT ALLEGATION IS CONFIRMED. VISUAL INSPECTION, REVEALS THAT THE EDGES AROUND THE THREADED AREA OF THE BUTTON WERE CHIPPED/DAMAGED. THREADS AT THE DISTAL END OF THE SHAFT WERE STRIPPED. THE BUTTON WAS RETURNED DISASSEMBLED FROM THE SHAFT. FUNCTIONAL TESTING WAS NOT PERFORMED DUE TO THE DAMAGE TO THE DEVICE. PER SURGICAL TECHNIQUE - LT1-000162-EN - 1-THROUGH AN OPEN OR MINI-OPEN INCISION, DRILL A 3.7 MM TUNNEL THROUGH BOTH THE CLAVICLE AND CORACOID. FLUOROSCOPY CAN BE USED TO CONFIRM PROPER TUNNEL PLACEMENT. THE METHOD OF BONE PREPARATION AND THE QUALITY OF THE BONE ENCOUNTERED WERE NOT SPECIFIED. THE MOST LIKELY CAUSE OF THE REPORTED FAILURE IS ATTRIBUTED TO USER ERROR RESULTING FROM IMPROPER SURGICAL TECHNIQUE. CONTRIBUTING FACTORS MAY INCLUDE INADEQUATE BONE PREPARATION, MISALIGNMENT/PRYING OR LEVERAGING OF THE DEVICE DURING INSERTION, WHICH COULD LEAD TO THE BUTTON SEPARATING OR DISENGAGED FROM THE SHAFT.

Additional Manufacturer Narrative

COMPLAINT ALLEGATION IS NOT CONFIRMED. BASED ON THE INFORMATION PROVIDED, WHICH MAY INCLUDE THE DEVICE (IF AVAILABLE AND RETURNED), PICTURES, VIDEOS, EVENT DESCRIPTION, AND ANY ADDITIONAL INFORMATION FROM THE FIELD, ARTHREX WAS ABLE TO CONCLUDE THE MOST LIKELY CAUSE. THE MOST LIKELY CAUSE OF THE REPORTED FAILURE IS USER ERROR, INCLUDING INCORRECT SURGICAL TECHNIQUE DURING DEVICE APPLICATION. THESE FACTORS MAY HAVE CONTRIBUTED TO THE MALFUNCTION OR COMPROMISED THE INTEGRITY OF THE IMPLANT DURING THE PROCEDURE. THE DEVICE WAS NOT RECEIVED FOR EVALUATION.

Description of Event or Problem

IT WAS REPORTED THAT DURING A SURGERY THE IMPLANT DID NOT HOLD. NO FURTHER INFORMATION RECEIVED. UPDATE DW 20-NOV-2025: FURTHER INFORMATION WAS PROVIDED THAT THE FIRST ARTHREX EMPLOYEE BECAME AWARE OF THIS ISSUE ON 28TH OCTOBER 2025. IT WAS FURTHER REPORTED THAT THE ISSUE OCCURRED DURING A SHOULDER SURGERY. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY. UPDATE DW 21-NOV-2025: FURTHER INFORMATION WAS PROVIDED THAT THE REPORTED DEVICE HAS THE BATCH 15446460.