Arthrex® AR-9215-2CGRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867192591), received between Dec 27, 2021 and Dec 27, 2021 — 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. 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.

• MalfunctionDec 27, 2021Break; Particulates; Defective Device; Output Problem

  AT THIS TIME, NO DESCRIPTION OF THE ERROR WAS RECEIVED WITH THIS DEVICE. THE INFORMATION HAS BEEN REQUESTED. UPDATE 07-DEC-2021: ACCORDING TO SURGICAL TECHNICAL ASSISTANT: THE DEFECT IN THE CANNULATED BURR SMALL IS DUE TO MONTHS OF USE. AFTER ALL, THE WIRES FROM ARTHREX JUST BARELY FIT THROUGH THE OPENING, CAUSING THEM TO BREAK THROUGH REPEATED USE. UNFORTUNATELY, THIS LEADS TO INCREASED METAL ABRASION IN THE SHOULDER. THE PATIENT WAS NOT HARMED. UPDATE 07-DEC-2021: IT IS NOT ABOUT A DRILL GUIDE BUT ABOUT THE TEMPLATE AR-9215-2CG GLENOID DRILL GUIDE, NAUTILUS, SMALL. THIS ITEM HAS VERY TIGHT HOLES FOR THE DRILL AND DUE TO DRILLING THROUGH OVER THE LAST FEW YEARS THERE IS NOW METAL ABRASION. THE METAL ABRASION HAS BEEN REMOVED FROM PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13087702 ↗