Arthrex® AR-2324BSLMRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867026896), received between Oct 5, 2016 and Oct 5, 2016 — classified as 1 injury.

The most frequently reported specific device problem is “Difficult to Remove” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryOct 5, 2016Difficult to Remove

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR, THE AR-2324BSL (BIO-SWIVELOCK SP, 4.75 MM X 24.5 MM, SELF-PUNCHING) WAS USED. THE SURGEON ATTEMPTED TO INSERT THE ANCHOR THREE TIMES AND ON THE THIRD ATTEMPT THE SELF PUNCH TIP AND PART OF THE SWIVELOCK ANCHOR BECAME IMPLANTED AND COULD NOT BE REMOVED. THE SURGEON REPORTED TO THE SALES REP THAT WHAT REMAINED IN THE PATIENT WAS SECURE. THE SURGEON WAS ABLE TO TIE THE SUTURE FROM THE ANCHOR INTO THE ROTATOR CUFF AND BRING THE TENDON DOWN OVER THE IMPLANTED ANCHOR. SURGEON ALSO PLACED ANOTHER SWIVELOCK AND INCORPORATED IT INTO THE REPAIR. SALES REP STATES IT IS UNCLEAR IF THE ADDITIONAL ANCHOR WAS "BUDDIED UP" OR PLACED CLOSE TO THE BROKEN ANCHOR. IT WAS REPORTED THAT THE SURGEON FELT EVERYTHING WAS SECURE. CASE WAS COMPLETED AS PLANNED. NO X-RAYS WERE TAKEN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6000519 ↗