Arthrex® AR-8963ML-10Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867233553), received between Feb 13, 2025 and Feb 13, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Use of Device Problem” (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.

• MalfunctionFeb 13, 2025Use of Device Problem; Use of Device Problem

  ON (B)(6) 2025, AN FDA MEDWATCH NOTIFICATION WAS RECEIVED VIA EMAIL. A FACILITY REPRESENTATIVE REPORTED THAT A PLATE AND MULTIPLE SCREWS WERE IMPLANTED IN A PATIENT. TWO ARTHREX SCREWS BROKE DURING IMPLANTATION. ONE SCREW WAS SUCCESSFULLY REMOVED, AND THE OTHER SCREW WAS PARTIALLY REMOVED. THE PARTIAL SCREW WAS LEFT IN PLACE. THE PROCEDURE WAS PERFORMED UNDER FLUOROSCOPY, AND THE PARTIAL SCREW WAS OBSERVED BY THE OPERATING ROOM STAFF AND THE SURGEON. THIS WAS DISCOVERED DURING AN ANKLE FRACTURE PROCEDURE ON (B)(6) 2025. NO FURTHER INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION WAS PROVIDED ON 2/5/2025: THE FACILITY REPRESENTATIVE PROVIDED PART AR-8835CL-32 KREULOCK COMPRESSION SCREW AS THE SCREW THAT WAS REMOVED ENTIRELY. THE AR-8835CL-36 KREULOCK COMPRESSION SCREW WAS PARTIALLY REMOVED. THE AR-8963ML-10 MEDIAL DISTAL TIBIA PLATE REMAINED IN THE PATIENT AND SUFFERED NO DAMAGE OR MALFUNCTION. THE CASE WAS COMPLETED USING THE SAME PLATE WITH NEW SCREWS. THE CASE WAS NOT DELAYED, AND ADDITIONAL ANESTHESIA WAS NOT NEEDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 21375721 ↗