Arthrex® AR-11880Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867003729), received between Sep 24, 2018 and Sep 24, 2018 — 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.

• InjurySep 24, 2018Break; Material Fragmentation

  IT WAS REPORTED THAT UPON INSPECTION OF THE BIRD BEAK, IT WAS FOUND TO HAVE A BROKEN TIP. THIS WAS NOTICED AT THE DISTRIBUTOR OFFICE. THE DEVICE WAS LAST USED IN A RCR PROCEDURE. NO ATTEMPT WAS MADE TO RETRIEVE THE BROKEN FRAGMENT AS IT WAS TOO SMALL TO BE NOTICED. UPDATED INFORMATION OBTAINED NOV. 7, 2018: UPON RECEIPT OF THE COMPLAINT DEVICE IT WAS DISCOVERED THAT THE ORIGINAL LOT NUMBER REPORTED (LOT 82809) WAS INCORRECT. THE CORRECT LOT NUMBER OF THE COMPLAINT DEVICE WHICH WAS RETURNED TO ARTHREX IS LOT 13239.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7901807 ↗