Arthrex® AR-9231-02AG-25LRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867350274), received between Nov 1, 2022 and Dec 27, 2022 — 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.

• MalfunctionDec 27, 2022Break

  IT WAS REPORTED ON (B)(6) 2022 BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-9215-1-03 HANDLE SNAPPED OFF THE AR-9231-02AG-25L DRILL GUIDE. CASE INVOLVEMENT, DEVICE BROKE DURING USE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16051738 ↗
• MalfunctionNov 1, 2022Break

  ON 10/11/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-9231-02AG-25L UNIVERS VAULTLOCK AUGMENTED GLENOID DRILL GUIDE AND AN AR-9215-1-03 UNIVERSAL QUICK CONNECT HANDLE HAD AN ISSUE. DURING AN ANATOMIC TOTAL SHOULDER REPLACEMENT PROCEDURE ON (B)(6) 2022, THE SURGEON SNAPPED OFF THE 25 DEGREE MEDIUM LEFT AUGMENTED VAUTLOCK DRILL GUIDE INTRAOPERATIVELY. NO PIECE BROKE OFF INSIDE THE PATIENT. THEY PLACED THE DRILL GUIDE BY HAND-HOLDING ORIENTATION WITH A COKER WHILE THE SUPERIOR DRILL BIT WAS DRIVEN TO A POSITIVE STOP. THE CASE WAS COMPLETED SUCCESSFULLY. THIS WAS DISCOVERED DURING USE WITH NO IMPACT TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED. ON 10/11/2022, THE SALES REPRESENTATIVE STATED THE FOLLOWING INFORMATION VIA PHONE: THE INSTRUMENTS WERE WITHIN THE INCISION INSIDE THE PATIENT WHEN THEY BROKE, BUT ALL FRAGMENTS WERE RETRIEVED FULLY. THE CASE WAS COMPLETED SUCCESSFULLY WITH NO IMPACT TO THE PATIENT. BOTH COMPLAINT DEVICES ARE AVAILABLE FOR RETURN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15710034 ↗