LOW-PROFILE AC IMPLANT DEVICE
Received Apr 13, 2026 · Event occurred Mar 23, 2026
Report 1220246-2026-02165 · MDR key 24856766
Device
Generic name
Washer, Bolt, Nut
Manufacturer
Arthrex, Inc.Model number
LOW-PROFILE AC IMPLANT DEVICECatalog number
AR-2370
Lot number
15172469
Product problems
- Positioning Failure
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 (B)(6) 2026, AN ARTHREX SUBSIDIARY EMPLOYEE REPORTED VIA EMAIL THAT AN AR-2370 LOW PROFILE AC TIGHTROPE EXPERIENCED AN ISSUE DURING INTRA-ARTICULAR INSERTION. THE BUTTON CAME LOOSE FROM THE ADJUSTMENT LOOP AND CONTRACTED, RENDERING THE DEVICE UNUSABLE. THE DEVICE WAS REMOVED FROM THE PATIENT AND REPLACED WITH ANOTHER AR-2370 LOW PROFILE AC TIGHTROPE TO COMPLETE THE PROCEDURE. THERE WAS NO SIGNIFICANT SURGICAL DELAY, NO ADDITIONAL ANESTHESIA ADMINISTERED, AND NO PATIENT HARM REPORTED. THE ISSUE OCCURRED DURING AN ACROMIOCLAVICULAR JOINT REPAIR PROCEDURE ON (B)(6) 2026.