Arthrex® AR-8941-7Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867051737), received between Jun 6, 2022 and Nov 26, 2025 — classified as 1 injury, 1 malfunction.

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. How this data works · Data updated Oct 13, 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 26, 2025Break; Break

  ON 11/6/2025, AN FDA MEDWATCH NOTIFICATION WAS RECEIVED VIA EMAIL. A FACILITY REPRESENTATIVE REPORTED THAT THE TIP OF AN AR-8941-7 LONG GUIDE WIRE WAS MISSING AFTER USE. IMAGING WITH A C-ARM REVEALED THAT THE TIP REMAINED IN THE PATIENT¿S SHOULDER AND WAS SUBSEQUENTLY REMOVED. THIS ISSUE WAS IDENTIFIED DURING A PROCEDURE.

  Patient problems: Insufficient Information

  MAUDE report 23656053 ↗
• InjuryJun 6, 2022Difficult to Remove; Mechanical Jam

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY THE PINS GOT STUCK IN THE CANNULATED SPINDLE. WITH THE PIN BEING SHORTER THAN THE SPINDLE, IT WAS IMPOSSIBLE TO REMOVE IT WITH PLIERS. WHILE FORCING TO REMOVE IT, A NURSE WAS INJURED, WHICH RESULTED IN A BLOOD EXPOSURE ACCIDENT. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: Exposure to Body Fluids; Unspecified Tissue Injury

  MAUDE report 14603630 ↗