Arthrex® AR-8500CRERecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867043787), received between Jul 26, 2016 and Jul 26, 2016 — classified as 1 injury.

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 18, 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.

• InjuryJul 26, 2016Break

  IT WAS ORIGINALLY REPORTED THAT THE CUSTOMER RETURNED A SHAVER/BURR WITH A BROKEN TIP. NO ITEM OR LOT# PROVIDED AT THAT TIME, NO MORE INFORMATION PROVIDED BY CUSTOMER. THE SALES REP REPORTED THAT THE TIP OF A SHAVER BROKE DURING SURGERY AND TIP REMAINED IN PATIENT'S BODY AS IT COULD NOT BE REMOVED. ADDITIONAL INFORMATION OBTAINED 07-JULY-2016: IT WAS REPORTED THAT THE PROTECTION CAP AT THE TIP OF THE BURR GOT LOST DURING THE SURGERY. THE PROTECTION CAP WAS NOT RETURNED FOR EVALUATION. CUSTOMER COULD NOT CONFIRM THAT PROTECTION CAP WAS LEFT INSIDE OF PATIENT'S BODY. SURGERY PERFORMED WAS A HIP ASK. SURGERY WAS SUCCESSFULLY FINISHED USING ANOTHER BURR WITH THE SAME ITEM NUMBER. DATE OF SURGERY WAS (B)(6) 2016.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 5823519 ↗