Arthrex® AR-8951MRRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867054813), received between Sep 5, 2024 and Sep 5, 2024 — 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 5, 2024Break; Break

  ON 8/12/2024, IT WAS REPORTED BY A PATIENT VIA EMAIL THAT A CANCELLOUS COMPRESSION SCREW, BEING USED WITH A TROCAR TIP TO STABILIZE A LISFRANC INJURY, BROKE OFF IN THE FOOT. THE BROKEN FRAGMENTS WERE NOT REMOVED. ON (B)(6) 2024, THE PATIENT REPORTED THAT THE PROCEDURE TOOK PLACE ON (B)(6) 2024 IN WHICH AN AR-8935CL-26 KREULOCK COMPRESSION SCREW, AN AR-8935-22 NON-LOCKING LOW PROFILE SCREW, AN AR-8935CL-32 KREULOCK COMPRESSION SCREW, AND AN AR-8951MR MEDIUM RIGHT LISFRANC PLATE WAS IMPLANTED. ADDITIONALLY, ANOTHER PLATE AND 5 SCREWS WITH UNKNOWN PART NUMBERS WERE ALSO IMPLANTED. DURING THE PROCEDURE, ONE OF THE SCREWS BROKE ABOUT THE FIFTH THREAD DOWN. AT THIS TIME, IT IS UNKNOWN WHICH SCREW BROKE. THE SURGEON DECIDED TO LEAVE THE BROKEN FRAGMENT IN THE PATIENT, AS REMOVING IT WOULD CAUSE MORE HARM. ONCE THE PATIENT WAS HEALED, ON (B)(6) 2024, A SECOND PROCEDURE WAS PERFORMED TO REMOVE BOTH PLATES AND EIGHT SCREWS, EXCEPT THE BODY OF THE PREVIOUSLY BROKEN SCREW. THE PART NUMBER FOR THE TROCAR TIP REMAINS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 20146609 ↗