KNOTLESS AC TIGHTROPE OPEN REPAIR IMPLAN

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 11/6/2025, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT THE THREADED PORTION OF THE INSERTER FOR AN AR-2372BLO KNOTLESS AC TIGHTROPE OPEN REPAIR IMPLANT BROKE OFF IN THE BUTTON PRIOR TO INSERTION. THE IMPLANT WAS DISCARDED BECAUSE IT COULD NOT BE ADVANCED THROUGH THE CLAVICLE OR CORACOID WITHOUT SLIPPING OFF THE INSERTER. THERE WERE NO ADVERSE EFFECTS ON THE PATIENT, AND THE CASE PROCEEDED WITHOUT DELAY. THIS WAS DISCOVERED DURING AN AC JOINT RECONSTRUCTION PROCEDURE ON (B)(6) 2025. ADDITIONAL INFORMATION WAS RECEIVED ON 11/12/2025: THE FAILED AR-2372BLO KNOTLESS AC TIGHTROPE OPEN REPAIR IMPLANT WAS REMOVED FROM THE PATIENT, AND A REPLACEMENT AR-2372BLO KNOTLESS AC TIGHTROPE OPEN REPAIR IMPLANT (FROM LOT: 15204430) WAS USED AFTER THE INITIAL FAILURE.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: G3, H3, H6. BASED ON THE INFORMATION PROVIDED ¿ WHICH MAY INCLUDE THE RETURNED DEVICE (IF AVAILABLE), PHOTOGRAPHS, VIDEOS, EVENT DESCRIPTION, AND ANY ADDITIONAL FIELD INPUT ¿ ARTHREX HAS DETERMINED THE MOST LIKELY CAUSE. THE MOST LIKELY CAUSE IS ATTRIBUTED TO USER-RELATED FACTORS SUCH AS EXCESSIVE USER-APPLIED MECHANICAL FORCES OR OFF-AXIS LOADING RESULTING IN THE THREAD SHEAR OR FRACTURE OF THE THREADED TIP.