Arthrex® AR-9231-VL-03Recalls & reported problems
Arthrex, Inc. · MODULAR VAULTLOCK DRILL GUIDE, LARGE · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00888867398955), received between Jan 19, 2024 and Feb 24, 2026 — 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.
Reports received per month
Most reported problems
Device problems
- Break3
- Positioning Failure1
Patient problems
- Insufficient Information2
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 24, 2026Positioning Failure
ON 06-FEB-2026, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT THE AR-9231-VL-03 MODULAR VAULTLOCK DRILL GUIDE IS MISALIGNED AS A RESULT FROM OFF-ACCESS DRILLING. THIS ISSUE WAS DISCOVERED DURING A CASE WITH NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24429040 ↗MalfunctionFeb 11, 2025Break; Break
ADDITIONAL INFORMATION WAS RECEIVED ON 02/28/2025: THERE WAS NO CASE DELAY OR ADDED ANESTHESIA ADMINISTERED TO THE PATIENT. NO ADVERSE EFFECTS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21354205 ↗MalfunctionMay 10, 2024Break; Break
ON 04/15/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9215-1-03 UNIVERSAL QUICK CONNECT HANDLE AND AN AR-9231-VL-03 GLENOID DRILL GUIDE BROKE AND COULD NOT BE TAKEN APART. THIS OCCURRED DURING A CASE WHERE THE DEVICES WERE SWITCHED OUT, AND THE CASE CONTINUED WITH NO FURTHER ISSUE.
Patient problems: Insufficient Information
MAUDE report 19292815 ↗MalfunctionJan 19, 2024Break; Break
ON 12/28/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-9236-03PP UNIVERS VAULTLOCK GLENOID TRIAL, LARGE AND AN AR-9215-1-03 UNIVERSAL QUICK CONNECT HANDLE SHAFT BROKE FOR AN AR-9231-VL-03 UNIVERS VAULTLOCK GLENOID DRILL GUIDE BROKE. THIS WAS DISCOVERED DURING A TSA PROCEDURE ON (B)(6) 2023.
Patient problems: Insufficient Information
MAUDE report 18547768 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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