Arthrex® AR-8655-09Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867044319), received between Jul 25, 2022 and Jul 25, 2022 — classified as 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. 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.

• MalfunctionJul 25, 2022Break

  ON (B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-8655-09 OSTEOTOME, ANKLE ARTHROSCOPY, CURVED BROKE DURING THE BONE PREPARATION OF THE ANKLE. THE SURGEON NOTICED THE OSTEOTOME WAS ALREADY WEAKENED. THIS OCCURRED DURING AN ANKLE FUSION PROCEDURE ON (B)(6) 2022, THE TIP OF THE BLADE BROKE IN THE MIDDLE OF THE ARTHROSCOPY, THE BROKEN PIECE WAS FULLY RETRIEVED AND THE PROCEDURE WAS COMPLETED, NO SECOND SURGERY WAS NECESSARY. THE EVENT OCCURRED DURING THE INITIAL/FIRST TIME USE OF THE DEVICE. THIS WAS DISCOVERED DURING USE WITH NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15093216 ↗