Arthrex® AR-9231-02AG-25RRecalls & reported problems
Arthrex, Inc. · AUGMENTED VAULTLOCK DRILL GUIDE, M 25R · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867350267), received between May 21, 2024 and May 21, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Defective Device” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Defective Device1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 21, 2024Defective Device; Defective Device
ON 2/28/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-9215-1-03 UNIVERSAL QUICK CONNECT HANDLE SNAPPED OFF AND GOT STUCK INSIDE AN AR-9231-02AG-25R GLENOID DRILL GUIDE. NOTHING BROKE INSIDE THE PATIENT, AND THE CASE WAS COMPLETED SUCCESSFULLY WITHOUT FURTHER ISSUES. THIS WAS DISCOVERED DURING AN ECLIPSE TSA PROCEDURE ON (B)(6) 2023. ADDITIONAL INFORMATION RECEIVED ON 2/23/2023: CASE WAS COMPLETED BY UTILIZING A MALLET AND POLY TIPPED IMPACTOR TO GENTLY SECURE GLENOID DRILL GUIDE IN GLENOID. THE 6MM SUPERIOR DRILL WAS DRILLED AND HELD THE GUIDE IN PLACE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19360384 ↗
Other ORTHOPEDIC MANUAL SURGICAL INSTRUMENT devices
- AML EXCEL 2001-42-000Depuy (Ireland) · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT2,009 reports
- NA 03.010.523Synthes GmbH · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1,208 reports
- EXPRESSEW 214141Medos International Sàrl · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1,166 reports
- N/A 9560524Medtronic Sofamor Danek, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT866 reports
- INHANCE 6500-11-104Depuy (Ireland) · Orthopedic manual surgical instrument831 reports
- INHANCE 6500-11-102Depuy (Ireland) · Orthopedic manual surgical instrument567 reports
- R3 71364450Smith & Nephew, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT520 reports
- N/A 9561524Medtronic Sofamor Danek, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT494 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page