Arthrex® AR-8935-42Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867050686), received between Mar 13, 2023 and Mar 13, 2023 — 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.

• InjuryMar 13, 2023Break; Break

  ADDITIONAL INFORMATION IS RECEIVED ON 2/21/2023: THE CASE WAS COMPLETED AFTER ADDING THREE MORE SCREWS TO THE PLATE. THE BROKEN BODY OF THE SCREW WAS LEFT IN PLACE. THE BODY OF THE SCREW HAD NO HEAD, THEREFORE, THERE WAS NO WAY TO REMOVE THE SCREW. THIS WAS DISCOVERED DURING AN ORIF OF A NON-UNION MEDIAL MALLEOLUS FRACTURE. A 6-HOLE 1/3 TUBULAR PLATE WAS USED FROM THE SAME TITANIUM ANKLE FRACTURE SET- THE PLATE WAS NOT CHANGED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Foreign Body Reaction

  MAUDE report 16528642 ↗