Arthrex® AR-8835-34Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867047389), received between Jan 26, 2021 and Jan 26, 2021 — 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.

• InjuryJan 26, 2021Break

  IT WAS REPORTED THAT DURING A TIBIA AND FIBULA OSTEOTOMY (ANKLE FRACTURE) PROCEDURE (B)(6) 2021 THE SURGEON WAS INSERTING A 3.5 CORTICAL SCREW, AR-8835-34 (LOT UNKNOWN), AND THE HEAD OF THE CORTICAL SCREW BROKE OFF. THE DRIVER AR-8943-12 (LOT 4751509) BEING USED DID NOT BREAK, JUST THE SCREW HEAD BROKE OFF. THE BONE SOCKET WAS PREPARED PROPERLY USING A 2.5 DRILL BIT (AR-8943-42) AND A LOCKING TOWER FOR PREPARATION FOR SCREW INSERTION. SURGEON FOLLOWED BY USING TWO T15 DRIVERS, ONE ON POWER FOLLOWED BY HAND. THE BONE QUALITY WAS REPORTED TO BE GOOD. THE SURGEON WAS ABLE TO USE A LOCKING SCREW PROXIMAL TO WHERE THE BROKEN SCREW WAS PLACED. THE CASE WAS COMPLETED.

  Patient problems: Insufficient Information

  MAUDE report 11228598 ↗