Arthrex® AR-8954-05Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867055261), received between Mar 6, 2025 and Mar 6, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Patient Device Interaction 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.

• MalfunctionMar 6, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  ON 02/19/2025, A FACILITY REPRESENTATIVE REPORTED VIA (B)(4) THAT AN AR-8880-01 RASP AND BLUNT ELEVATOR SMALL, AR-8880-02 RASP AND BLUNT ELEVATOR MEDIUM, AR-8880-03 COMBI-ELEVATOR STRAIGHT AND CURVED ENDS, AND AN AR-8954-05 ELEVATOR SAYRE 9MM X6.5'' HANDLES ARE THIN AND REQUIRE A TIGHT GRIP THAT FATIGUES THE HAND. THE SHARP EDGE IS TOO SHARP, AND IN SOME BONE, IT GOES INTO THE BONE - WHICH IS NOT THE IDEAL ASPECT. IT SHOULD BE MORE LIKE A FREER TIP VS A SHARP EDGE. THIS OCCURRED DURING A CASE. THERE WAS NO ADDITIONAL INFORMATION PROVIDED, AND ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21535530 ↗