Arthrex® AR-8500COTRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867043770), received between Feb 7, 2022 and Feb 7, 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.

• MalfunctionFeb 7, 2022Break

  IT WAS REPORTED THAT DURING A SAS SURGERY THE PLASTIC PROTECTIVE CAP OF THE BURR BROKE OFF INSIDE THE PATIENT. IT WAS FURTHER REPORTED THAT THE CAP COULD NOT BE RETRIEVED AND AN ADDITIONAL SURGERY IS NEEDED TO RETRIEVE THE BROKEN DEVICE OUT OF THE PATIENT. 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: Insufficient Information

  MAUDE report 13471865 ↗