Arthrex® AR-9231-VL-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867398931), received between Apr 18, 2025 and Aug 4, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 4, 2025Break; Break

  ON (B)(6) 2025, A FACILITY REPRESENTATIVE REPORTED VIA (B)(4) THAT THE TIP OF AN AR-9215-1-03 QUICK CONNECT HANDLE BROKE OFF WITHIN AN AR-9231-VL-01 DRILL GUIDE DURING A CASE, BUT THE PATIENT WAS NOT AFFECTED. ADDITIONAL INFORMATION RECEIVED ON 07/18/25: THERE WAS DAMAGE TO THE VAULTLOCK DRILL GUIDE (PLEASE SEE ATTACHED IMAGE). THERE WERE NO LOOSE FRAGMENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22701853 ↗
• MalfunctionApr 18, 2025Break; Break

  ON 03/25/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(6) THAT THE TIP OF THE AR-9215-1-03 QUICK CONNECT HANDLE BROKE OFF IN THE ATTACHMENT SLOT ON THE SMALL AR-9231-VL-01 GLENOID DRILL GUIDE. THIS HAPPENED AFTER THE SURGEON DRILLED THE SUPERIOR HOLE AND INFERIOR KEEL AND REMOVED THE GUIDE. THE GUIDE WAS EASILY REMOVED FROM THE GLENOID. NO PIECES BROKE OFF INSIDE THE PATIENT, AND THE CASE WAS COMPLETED SUCCESSFULLY. THIS WAS DISCOVERED DURING A TOTAL SHOULDER ARTHROPLASTY PROCEDURE ON (B)(6) 2025, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21865323 ↗