Arthrex® AR-9236-02AG-15RRecalls & reported problems
Arthrex, Inc. · AUGMENTED VAULTLOCK TRIAL, MEDIUM 15R · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888867350816), received between May 25, 2023 and Sep 16, 2026 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Break” (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
- Break1
- Crack1
- Material Separation1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Insufficient Information1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 16, 2026Material Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50793314 ↗MalfunctionOct 18, 2023Crack; Crack
ON 9/20/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-06036695 THAT AN AR-9236-02AG-15R UNIVERS VAULTLOCK AUGMENTED GLENOID TRIAL, MEDIUM 15 ° RIGHT, HAD AN ISSUE DURING A TSA-ECLIPSE PROCEDURE PM (B)(6) 2023. WHEN REMOVING THE PEGGED AUGMENT TRIAL, THE CENTRAL PEG CRACKED RIGHT BEFORE IT WAS COMPLETELY OUT OF BONE. IT WAS STILL ATTACHED TO THE TRIAL, BUT THE PLASTIC AROUND THE CENTRAL METAL PEG WAS CRACKED. NO PIECE BROKE OFF INSIDE THE PATIENT. THERE WAS NO HARM TO THE PATIENT, AND THEY WERE PAST THE POINT OF NEEDING TO TRIAL AGAIN. THE CASE WAS COMPLETED SUCCESSFULLY WITHOUT COMPLICATION. THE COMPLAINT DEVICE WAS DISCARDED. THIS OCCURRED DURING USE WITH NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED. ON 10/3/2023, THE SALES REPRESENTATIVE PROVIDED THE FOLLOWING INFORMATION VIA EMAIL: THERE WAS NO CASE DELAY REPORTED. NO PICTURE WAS TAKEN AS THE BROKEN TRIAL WAS THROWN OUT BY SPD BEFORE THEY CAME OUT OF THE WASH TO PUT THE TRAYS BACK TOGETHER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17958734 ↗MalfunctionMay 25, 2023Break; Break
ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-9236-02AG-15R AUGMENTED GLENOID TRIALS CENTRAL PEG BROKE OFF. THIS OCCURRED DURING A TSA- AUGMENTED VAULTLOCK ON (B)(6) 2023 AFTER FULLY PREPPING THE GLENOID AND INSERTING THE PEGGED VAULTLOCK TRIAL, THE CENTRAL PEG BROKE OFF THE TRIAL WHEN THE SURGEON WAS PULLING IT OUT. THE PEG WAS THEN RETRIEVED AND THE CASE WAS COMPLETED WITHOUT INCIDENT.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 17003110 ↗
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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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