Arthrex® AR-9241-03Recalls & reported problems
Arthrex, Inc. · GLENOID INSERTER/IMPACTOR, LARGE · Class 1
Data updated Oct 16, 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 00888867377134), received between Dec 6, 2024 and Aug 20, 2025 — classified as 3 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Break3
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 20, 2025Break; Break
ON (B)(6) 2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-07008709 THAT AN AR-9241-03 GLENOID INSERTER/IMPACTOR AUGMENTED VAULT LOCK INSERTER BROKE. THIS WAS DISCOVERED DURING THE CASE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE WITH NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22850241 ↗MalfunctionAug 1, 2025Break; Break
ON 07/11/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9241-03 GLENOID INSERTER/IMPACTOR BROKE. THE INSTRUMENT WAS USED CORRECTLY BUT THE BLUE IMPACTOR PIECE BROKE OFF THE SILER INSERTER. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22686911 ↗MalfunctionDec 6, 2024Break; Break
ON 11/08/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9241-03 UNIVERS VAULTLOCK® GLENOID INSERTER HAD THE BLUE IMPACTOR BREAK OFF DURING THE CASE. THE PATIENT WAS NOT AFFECTED. THIS WAS DISCOVERED DURING A PROCEDURE, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20864192 ↗
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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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