inforMED
MalfunctionHTN

KNOTLESS AC TIGHTROPE OPEN REPAIR IMPLAN

Received Apr 10, 2026 · Event occurred Mar 13, 2026

Report 1220246-2026-02137 · MDR key 24844258

Device

Generic name

Washer, Bolt, Nut

Manufacturer

Arthrex, Inc.

Catalog number

AR-2372BLO

Lot number

15516193

Product problems

  • Detachment of Device or Device Component

Patient

NA · Unknown

  • Insufficient Information

Narrative

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 20-MAR-2026, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT AN AR-2372BLO KNOTLESS AC TIGHTROPE OPEN REPAIR IMPLANT EXPERIENCED AN ISSUE DURING AN AC JOINT RECONSTRUCTION PROCEDURE ON (B)(6) 2026. THE IMPLANT BUTTON WAS NOT FULLY SECURED TO THE INSERTER AND DEPLOYED PREMATURELY DURING PASSAGE THROUGH THE CLAVICLE TUNNEL. THE PLASTIC COVER ON THE STYLET REMAINED IN PLACE AT THE TIME OF INSERTION. ALL COMPONENTS WERE RETRIEVED FROM THE PATIENT. A REPLACEMENT AR-2372BLO IMPLANT WAS USED TO COMPLETE THE PROCEDURE. THE CASE WAS DELAYED APPROXIMATELY TEN MINUTES, AND NO ADDITIONAL ANESTHESIA OR PATIENT HARM WAS REPORTED.