Arthrex® AR-9216-3Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867192621), received between Oct 23, 2019 and Feb 21, 2022 — classified as 1 injury, 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 21, 2022Break; Material Twisted/Bent

  ON 12/29/2021, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA SEMS THAT A AR-9216-3 GLENOID DRILL AND A AR-9215-4CGPP PIN GUIDE WERE DAMAGED. THIS OCCURRED ON (B)(6) 2021 DURING AN ECLIPSE TSA WHEN THE GUIDE BENT THE PIN , AND THE BENT PIN DAMAGED THE DRILL. ALL FRAGMENTS WERE RETRIEVED. THE CASE WAS COMPLETED SUCCESSFULLY BY PROCEEDING WITH A STANDARD PROCEDURE. THERE WAS NO PATIENT EFFECT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13569679 ↗
• InjuryOct 23, 2019Material Fragmentation

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROPLASTY PROCEDURE, A SMALL PIECE OF METAL FROM THE 6.0 CANNULATED DRILL (AR-9216-3) BROKE OFF IN THE PATIENT'S GLENOID. IT WAS NOT KNOWN AT THE TIME OF THE SURGERY ((B)(6) 2019) AND WAS DISCOVERED WHEN THE PATIENT CAME IN FOR A ROUTINE FOLLOW UP XRAY IN (B)(6). THERE WERE NO ISSUES DURING THE PROCEDURE OR WITH THE PATIENT AT FOLLOW UP. NO REVISION IS PLANNED. THERE IS A SMALL PIECE OF METAL VISIBLE ON XRAY IN THE GLENOID VAULT. ADDITIONAL INFORMATION PROVIDED 10/1/2019: THE PATIENT IS NOT EXPERIENCING DISCOMFORT. THE FRAGMENT APPEARS TO BE CONTAINED IN THE VAULT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9225721 ↗