KNOTLESS AC TIGHTROPE OPEN REPAIR IMPLAN
Received Mar 19, 2026 · Event occurred Feb 23, 2026
Report 1220246-2026-01536 · MDR key 24641702
Device
Generic name
Washer, Bolt, Nut
Manufacturer
Arthrex, Inc.Model number
KNOTLESS AC TIGHTROPE OPEN REPAIR IMPLANCatalog number
AR-2372BLO
Lot number
15117152
Product problems
- Failure to Advance
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 27-FEB-2026, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-2372BLO KNOTLESS AC TIGHTROPE BUTTON COULD NOT BE IMPLANTED. DURING THE PROCEDURE, THE SURGEON WAS UNABLE TO DRILL A SINGLE BONE TUNNEL THROUGH THE CLAVICLE AND CORACOID DUE TO THE NATURE OF THE PATIENT¿S BONE DISLOCATION. AS A RESULT, THE SURGEON ELECTED TO DRILL SEPARATE HOLES IN THE BONE AT DIFFERENT ANGLES. WHEN ATTEMPTING TO IMPLANT THE KNOTLESS AC TIGHTROPE DEVICE, THE DEVICE COULD NOT BE ADVANCED THROUGH THE SEPARATELY CREATED BONE HOLES, AS THE CONSTRUCT COULD NOT PASS THROUGH THIS TRAJECTORY. THE CASE WAS COMPLETED USING AN AR-2371BL KNOTLESS AC TIGHTROPE REPAIR SYSTEM INSTEAD. THIS ISSUE WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2026.