KNOTLESS AC TIGHTROPE OPEN REPAIR IMPLAN

Description of Event or Problem

ON (B)(6) 2026, A SALES REPRESENTATIVE REPORTED VIA PHONE THAT AN AR-2372BLO KNOTLESS AC TIGHTROPE OPEN REPAIR IMPLANT WITH PEC BUTTON WOULD NOT TENSION AND FAILED TO ACHIEVE AC JOINT REDUCTION. THE SURGEON ULTIMATELY CUT AND REMOVED THE IMPLANT AND TIED THE GRAFT OVER THE CONSTRUCT. THE CASE WAS DELAYED APPROXIMATELY FIVE MINUTES, WITH NO ADDITIONAL ANESTHESIA ADMINISTERED. THE ISSUE OCCURRED DURING A CLAVICLE ORIF AND AC JOINT STABILIZATION PROCEDURE WITH INTERNAL OPEN REDUCTION PERFORMED ON (B)(6) 2026. NO PATIENT HARM WAS REPORTED.

Additional Manufacturer Narrative

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

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 IF THE 3.7 MM TUNNELS THROUGH THE CLAVICLE AND CORACOID ARE NOT PROPERLY ALIGNED, THE IMPLANT MAY NOT SEAT CORRECTLY, PREVENTING EFFECTIVE TENSIONING AND REDUCTION.