Arthrex® AR-1324BFRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867010321), received between May 15, 2019 and May 15, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Break” (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.

• InjuryMay 15, 2019Break; Difficult to Remove

  DURING A FIXATION OF THE LABRUM CAPSULE THE ANCHOR BROKE OFF. ONE PART OF THE ANCHOR (WITH THE STRUCTURE) REMAIN ON THE DRIVER, THE OTHER PART REMAIN INSIDE THE PATIENT. THE SURGEON TRIED TO REMOVE IT BUT IT WAS NOT POSSIBLE TO REMOVE THE FRAGMENT. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY. UPDATE 25-APR: THE UNRETRIEVED FRAGMENT IS LOCATED AT THE GLENOID. THE PART OF THE ANCHOR ATTACHED TO THE DRIVER WAS DISCARDED. THE PATIENT DID NOT SUFFER ANY CONSEQUENTIAL DAMAGE OR IMPAIRMENT OF ANY KIND.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8611468 ↗