Arthrex® AR-9231-02PPRecalls & reported problems
Arthrex, Inc. · DRILL GUIDE, UNIVERS VAULTLOCK GLEN, MD · Class 1
Data updated Oct 16, 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 00888867239043), received between Jun 5, 2024 and Jun 5, 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 16, 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.
MalfunctionJun 5, 2024Defective Device; Defective Device
ON 08/18/2022, 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 19469661 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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