Arthrex® AR-9231-20Recalls & reported problems
Arthrex, Inc. · UNIVERS II VER ROD BRACKET FOR BROACH · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867137967), received between Jan 2, 2024 and Mar 17, 2026 — classified as 2 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Break1
- Physical Resistance/Sticking1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 17, 2026Break
ON (B)(6), IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-(B)(4) THAT AN AR-9231-20 BRACKET WAS STRUCK WITH A MALLET WHEN REMOVING AND SNAPPED. NOTICED DURING A CASE WITH NO PATIENT EFFECT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24618227 ↗MalfunctionJan 2, 2024Physical Resistance/Sticking; Physical Resistance/Sticking
ON 12/4/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9231-20 UNIVERS II VERSION ROD BRACKET FOR BROACH COLD WELDED IN THE CLIP AND BROKE OFF, AND CRESTED JAGGED METAL GOT STUCK. THIS WAS DISCOVERED DURING AN UNSPECIFIED TIME ON (B)(6) 2023, WITH NO REPORTED PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18430321 ↗
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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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