Arthrex® AR-9215-1-02Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00888867059023), received between Feb 1, 2021 and Jun 7, 2024 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (3 reports).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 7, 2024Break; Break

  ON (B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-9236-02PP UNIVERS VAULTLOCK¿ GLENOID TRIAL, MEDIUM, AN AR-9215-1-02 GLENOID DRILL GUIDE HANDLE, LONG AND AN AR-9231-02PP DRILL GUIDE, UNIVERS VAULTLOCK¿ GLENOID, MEDIUM HAD AN ISSUE DURING A TOTAL SHOULDER ARTHROPLASTY PROCEDURE ON (B)(6) 2022. IT WAS A TOUGH ANATOMIC SHOULDER ARTHROPLASTY CASE WITH TIGHT EXPOSURE. WHEN REMOVING THE MEDIUM VAULTLOCK DRILL GUIDE, THE THREADED TIP OF THE DRILL GUIDE HANDLE BROKE OFF INSIDE THE DRILL GUIDE, RENDERING BOTH INSTRUMENTS DEFECTIVE. LATER WHEN REMOVING THE MEDIUM VAULTLOCK TRIAL, THE CENTRAL PEG BROKE OFF. THE PIECE BROKE OFF INSIDE THE PATIENT, AND WAS RETRIEVED FROM THE PATIENT. THE CASE WAS COMPLETED SUCCESSFULLY. THE AR-9236-02PP WAS NOT AVAILABLE FOR RETURN AS IT WAS DISPOSED OF BY THE HOSPITAL STAFF. THIS WAS DISCOVERED DURING USE WITH NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19484327 ↗
• MalfunctionMar 29, 2021Crack

  IT WAS REPORTED, THAT THE AR-9215-01-02, GUIDE HANDLE HAS A CRACK IN THE THREADING. THIS IS NOW REPORTABLE. DURING RETURNED DEVICE EVALUATION, A REPORTABLE MALFUNCTION WAS DISCOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11585411 ↗
• MalfunctionFeb 3, 2021Break

  IT WAS REPORTED THAT THE TIP OF THE AR-9215-1-02 BROKE WHILE BEING REMOVED FROM THE PATIENT DURING AN APEX TOTAL SHOULDER PROCEDURE. ALL FRAGMENTS WERE FULLY RETRIEVED, AND THE DEVICE WAS NO LONGER NEEDED TO COMPLETE THE CASE. THE REP REPORTED THAT THE ISSUE DID NOT AFFECT THE OUTCOME NOR THE ACTUAL SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11274733 ↗
• MalfunctionFeb 1, 2021Break

  IT WAS REPORTED THAT THE METAL TIP ON THE AR-9215-1-02 GLENOID DRILL GUIDE HANDLE HAS BEEN COMPROMISED. AFTER INSERTION OF THE AR-601-TBP4 POLY TRIAL WITH THE HANDLE, THE METAL CONNECTION CRACKED CLEANLY OFF INTO THE TRIAL WHERE IT IS UNABLE TO BE REMOVED. THE REP REPORTED NO PIECES WERE LOST, AND BOTH PIECES WILL BE RETURNED. AS THE TRIAL HAD ALREADY BEEN PLACED, THERE WAS NO FURTHER NEED OF THE BASE PLATE TRIAL OR AN ALTERNATIVE INSTRUMENT. THERE WAS NO DELAY IN SURGERY, A SECOND SURGERY WILL NOT BE NEEDED.

  Patient problems: Failure of Implant

  MAUDE report 11258942 ↗