Arthrex® AR-9530L-03Recalls & reported problems
Arthrex, Inc. · UNIVERS REVERS TRIAL 42 +3 · Class 1
Data updated Oct 18, 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 00888867062061), received between Mar 18, 2024 and Nov 11, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (2 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
- Break2
Patient problems
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 11, 2024Break; Break
ON (B)(6) 2024, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT AN AR-9619-45 45MM REAMER BROKE DURING A CASE. ALL WERE RETRIEVED, AND THE CASE WAS CONTINUED. LATER, DURING THE CASE, THE AR-9530L-03 WAS USED, AND THE REP NOTICED IT HAD A LOT OF WEAR AND TEAR AND WOULD NEED TO BE REPLACED FOR THE NEXT TIME. IT WAS USED A LOT, AND PIECES WERE FALLING OFF. THE REP CONFIRMED NOTHING FELL INTO THE PATIENT AND THE CASE WAS COMPLETED SUCCESSFULLY WITHOUT A SIGNIFICANT DELAY.
Patient problems: Insufficient Information
MAUDE report 20653816 ↗MalfunctionMar 18, 2024Break; Break
ON 02/26/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9530L-03 REVERSE TRIAL BROKE. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT.ADDITIONAL INFORMATION REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18921756 ↗
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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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