KNOTLESS AC TIGHTROPE OPEN REPAIR IMPLAN
Received Jun 2, 2026 · Event occurred May 8, 2026
Report 1220246-2026-03114 · MDR key 25359381
Device
Generic name
Washer, Bolt, Nut
Manufacturer
Arthrex, Inc.Model number
KNOTLESS AC TIGHTROPE OPEN REPAIR IMPLANCatalog number
AR-2372BLO
Lot number
15542833
Product problems
- Detachment of Device or Device Component
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
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 13-MAY-2026, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT AN AR-2372BLO KNOTLESS AC TIGHTROPE OPEN REPAIR IMPLANT EXPERIENCED AN ISSUE IN WHICH THE BUTTON BROKE OFF THE INSERTER BUT REMAINED ATTACHED TO THE SUTURE. THIS WAS IDENTIFIED DURING AN AC JOINT RECONSTRUCTION PROCEDURE PERFORMED ON (B)(6) 2026. NO PATIENT HARM WAS REPORTED. ADDITIONAL INFORMATION WAS RECEIVED ON 21-MAY-2026: THE ISSUE OCCURRED DURING INSERTION INTO THE PATIENT. THE AFFECTED BUTTON AND SUTURES WERE REMOVED, AND ALL DETACHED FRAGMENTS WERE SUCCESSFULLY RETRIEVED. THE PROCEDURE WAS COMPLETED USING ANOTHER AR-2372BLO KNOTLESS AC TIGHTROPE OPEN REPAIR IMPLANT. THERE WAS AN APPROXIMATE DELAY OF 5-10 MINUTES, AND NO ADDITIONAL ANESTHESIA WAS ADMINISTERED.