Arthrex® AR-8901CRRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867048720), received between May 10, 2019 and May 10, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Defective Device” (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.

• InjuryMay 10, 2019Defective Device

  IT WAS REPORTED THAT DURING A PROCEDURE, THE CANNULATED CORING REAMER, AR-8901CR, TREPHINE WAS LOADED ONTO A DRILL. THE SURGEON THEN BEGAN TO REAM. WHEN HE CONTACTED THE BONE THE REAMER ¿BLEW OUT. REFORMING THE REAMER TO RESEMBLE A MUSHROOM. MUSHROOM MEANING ¿BLOWING OUT¿. NO FURTHER INFORMATION PROVIDED. FURTHER INFORMATION REQUESTED. ADDITIONAL INFORMATION PROVIDED ON 4/16/2019: THE PROCEDURE PERFORMED WAS A CALCANEUS OSTEOMYELITIS. THE CASE WAS COMPLETED BY ABORTING THE SPECIFIC PROCEDURE, HARVESTING BONE DOWEL FROM CALCANEUS.

  Patient problems: No Code Available

  MAUDE report 8600127 ↗