Arthrex® AR-8545-55Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867124776), received between Apr 13, 2021 and Apr 13, 2021 — classified as 1 malfunction.

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.

• MalfunctionApr 13, 2021Break

  IT WAS REPORTED THAT DURING AN ANKLE FUSION PROCEDURE, THE HEAD OF A 4.5X55MM SCREW, AR-8545-55, BROKE OFF WHILE THE SURGEON WAS INSERTING THE SCREW INTO THE COMPRESSION HOLE OF THE MIS FUSION PLATE. THE SCREW WAS ABLE TO BE REMOVED WITH BROKEN SCREW INSTRUMENTATION WITHOUT ANY HARM TO THE PATIENT. IMAGE ATTACHED. NO ADDITIONAL INFORMATION PROVIDED. FURTHER INFORMATION REQUESTED. ADDITIONAL INFORMATION PROVIDED ON 3/30/21: THE CASE WAS COMPLETED BY INSERTING A 5.5MMX55MM, AR-8555-55, LOT NUMBER UNKNOWN, AND PLACED SCREW IN THE SAME DRILL HOLE WITH NO OTHER ISSUES. THE COMPLAINT DEVICE WAS DISCARDED AFTER THE CASE AND WILL NOT BE RETURNED FOR EVALUATION.

  Patient problems: Failure of Implant

  MAUDE report 11655670 ↗