Arthrex® AR-9233AGRecalls & reported problems
Arthrex, Inc. · AUGMENTED VAULTLOCK BROACH · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00888867350366), received between Jan 4, 2024 and Feb 10, 2026 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Break” (5 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
- Break5
Patient problems
- No Clinical Signs, Symptoms or Conditions5
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 10, 2026Break
ON 21-JAN-2026, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9233AG BROACH MALLET POINT FELL OFF. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24305693 ↗MalfunctionJul 17, 2025Break; Break
ON 06/20/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9233AG BROACH BACK OF THE INSTRUMENT BROKE OFF WHILE BEING MALLETED. NOTHING BROKE INSIDE PATIENT. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22530103 ↗MalfunctionJun 3, 2025Break; Break
ON 05/14/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9233AG BROACH IS BROKEN. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22135395 ↗MalfunctionJul 24, 2024Break; Break
A SALES REPRESENTATIVE REPORTED VIA (B)(4) ON 07/03/2024 THAT AN AR-9233AG AUGMENTED VAULTLOCK BROACH HAD AN ISSUE. THE MALLET BROKE OFF WHEN THE SURGEON MALLEATED IT. THIS WAS DISCOVERED BEFORE USE DURING A PROCEDURE ON (B)(6) 2024, WITH NO REPORTED PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19820235 ↗MalfunctionJan 4, 2024Break; Break
ON 12/6/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE THAT AN AR-9233AG AUGMENTED VAULTLOCK BROACH BROKE WITH NO FURTHER INFORMATION PROVIDED. THIS WAS DISCOVERED DURING AN UNSPECIFIED PROCEDURE ON (B)(6) 2023, WITH NO REPORTED PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18443485 ↗
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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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