KNOTLESS AC TIGHTROPE OPEN REPAIR IMPLAN
Received May 21, 2026 · Event occurred Mar 26, 2026
Report 1220246-2026-02938 · MDR key 25242136
Device
Generic name
Washer, Bolt, Nut
Manufacturer
Arthrex, Inc.Model number
KNOTLESS AC TIGHTROPE OPEN REPAIR IMPLANCatalog number
AR-2372BLO
Lot number
15500856
Product problems
- Fracture
Patient
31 YR · Male
- Foreign Body In Patient
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 01-MAY-2026, ARTHREX RECEIVED AN ANONYMOUS MEDWATCH REPORT REGARDING AN EVENT THAT OCCURRED ON (B)(6) 2026 DURING A SHOULDER PROCEDURE FOR ACROMIOCLAVICULAR (AC) JOINT REPAIR. THE REPORT INDICATED THAT A PORTION OF THE AR-2372BLO KNOTLESS AC TIGHTROPE OPEN REPAIR IMPLANT FRACTURED INTRAOPERATIVELY DURING USE, LEAVING A FRAGMENT INSIDE THE PATIENT. THE ASSOCIATED CLINICAL CODE IDENTIFIED A FOREIGN BODY IN THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED.