Arthrex® AR-8500SRRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867043886), received between Jul 3, 2023 and Jul 3, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Fragmentation” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 3, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY, THE PLASTIC INSULATION ON THE SHAFT OF TWO OF THE DEVICES DETACHED. AT THE END OF THE PROCEDURE, THE SURGEON FOUND THAT ONE OR MORE OF THE DEVICES PRODUCED METAL DEBRIS INTRAOPERATIVELY. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW REUSABLE SHAVER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17246366 ↗