Arthrex® AR-8954-03Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867055254), received between Aug 3, 2021 and Nov 3, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 reports).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 3, 2025Break; Break

  ON 10/23/2025, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA (B)(4) THAT AN AR-8954-03 PLATE CUTTER TEETH BROKE DURING USE. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23450073 ↗
• MalfunctionAug 3, 2021Break

  IT WAS REPORTED THAT THE BLADE ON AR-8954-03 HERCULES PLATE CUTTER LOT: 561424 WAS BROKEN WHILE CUTTING A PLATE DURING A CASE. THE PATIENT WAS NOT HARMED AND THE CASE WAS COMPLETED BY USING A NEW AR-8954-03.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12267444 ↗