Arthrex® AR-9401-10Recalls & reported problems
Arthrex, Inc. · ECLIPSE & UNIVERS II RESECT GD S,LFT · 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 00888867060296), received between Sep 7, 2021 and Jun 4, 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Break2
- Mechanical Jam1
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.
MalfunctionJun 4, 2024Break; Break
IT WAS REPORTED THE AR-9401-10, SMALL LEFT GUIDE, VERSION ROD BROKE OFF IN THE HOLE AND CANNOT BE REMOVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19463518 ↗MalfunctionSep 7, 2021Break; Mechanical Jam
ON (B)(6) 2021, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA SEMS THAT AN AR-9401-10 ECLIPSE UNIVERSE THE PIN AND VERSION BECAME STUCK IN THE GUIDE CAUSING THE VERSION ROD TO BREAK. THIS WAS DISCOVERED DURING USE IN A SHOULDER ARTHROPLASTY ON (B)(6) 2021. THE CASE WAS COMPLETED BY FREE HAND CUT.
Patient problems: Insufficient Information
MAUDE report 12435082 ↗
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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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