Arthrex® AR-8655-15Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888867044371), received between Mar 5, 2019 and Dec 30, 2024 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 30, 2024Break; Break

  ON 12/03/2024 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-8655-15 RING CURETTE BROKE OFF INSIDE PATIENT DURING THE CASE BUT RETRIEVED WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21035442 ↗
• MalfunctionJun 13, 2024Break; Break

  ON 31-MAR-2023, IT WAS REPORTED BY A SALES REP VIA EMAIL THAT AN AR-8655-15, RING CURETTE, ANKLE ARTHROSCOPY, ANGLED WAS BROKEN. THIS WAS DISCOVERED DURING USE AND A CASE WAS INVOLVED. TO COMPLETE THE PROCEDURE, A DIFFERENT CURETTE WAS USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19533157 ↗
• InjuryMar 5, 2019Break

  IT WAS REPORTED THAT DURING AN ANKLE ARTHROSCOPY PROCEDURE, THE SURGEON WAS USING THE RING CURETTE IN A NORMAL FASHION WHEN THE TIP OF THE INSTRUMENT SNAPPED-OFF IN THE PATIENT. THE SURGEON WAS NOT USING ANY EXCESSIVE FORCE WHEN THIS HAPPENED. THE TIP WAS UNABLE TO BE RETRIEVED AND THUS REMAINED IN THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 8391651 ↗