Arthrex® AR-8655-12Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867044340), received between Dec 10, 2019 and Jul 12, 2023 — classified as 1 injury, 1 malfunction.

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.

• MalfunctionJul 12, 2023Break; Break

  ON (B)(6) 2023, IT WAS REPORTED BY A ARTHREX EMPLOYEE VIA SEMS THAT AN AR-8655-12 ELEVATOR ANKLE INSTRUMENT IS BROKEN. THIS WAS DISCOVERED DURING A CASE, DEVICE BROKE DURING USE.

  Patient problems: Insufficient Information

  MAUDE report 17304641 ↗
• InjuryDec 10, 2019Break

  IT WAS REPORTED DURING A MICROFRACTURE/DEBRIDEMENT OF OCD; BROSTRUM-GOULDE PROCEDURE THE AR-8655-13 WAS USED TO DEBRIDE OCD AND THE AR-8655-12 ELEVATOR ANKLE ARTHROSCOPY SHARP TIP BROKE OFF WITH MINIMAL APPLICATION / FORCE. THE REP STATED THE PROCEDURE STARTED ARTHROSCOPIC AND TURNED OPEN TO RETRIEVE THE BROKEN FRAGMENT. THREE INCISIONS WERE USED. THE TIP MIGRATED POSTERIORLY WHERE IT WAS FULLY RETRIEVED, AND THE CASE WAS COMPLETED. THE DEVICE AND RETRIEVED BROKEN FRAGMENT ARE AVAILABLE TO RETURN FOR EVALUATION.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9443623 ↗