Arthrex® AR-9401-13Recalls & reported problems
Arthrex, Inc. · ECLIPSE & UNIVERS II RESECT GD L,RT · Class 1
Data updated Oct 18, 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 00888867060326), received between May 10, 2024 and Feb 4, 2025 — classified as 3 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
- Material Deformation1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Insufficient Information1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 4, 2025Material Deformation; Material Deformation
IT WAS REPORTED THAT DURING A SURGERY APPARENTLY THE HOLES WERE SO DEFORMED THAT ONLY 1.6 K-WIRES COULD FIT THROUGH. IN ONE HOLE THE WIRE BROKE OFF AND BECAME STUCK. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. NO FURTHER INFORMATION RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21304117 ↗MalfunctionJun 13, 2024Break; Break
IT WAS REPORTED DURING DURING A HEMI SHOULDER ARTHROPLASTY PROCEDURE, THE VERSION ROD BROKE OFF THE AR-9401-13 HEAD CUT GUIDE. THE THREADED PORTION OF THE VERSION ROD IS NOW STUCK INSIDE THE GUIDE. THE CASE WAS STILL SUCCESSFUL AND NO HARM WAS DONE. SEE ATTACHED IMAGES. ADDITIONAL INFORMATION RECEIVED ON 5/26/2021: THE REP PROVIDED THE PART NUMBER OF THE VERSION ROD THAT BROKE DURING THE PROCEDURE (AR-9202). THE VERSION ROD BROKE WHILE THE GUIDE WAS IN USE. THE RODS ARE THREADED INTO THE TOP OF THE GUIDE, AND ARE NOT DIRECTLY IN THE PATIENT BUT ABOVE THE HUMERUS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19526626 ↗MalfunctionMay 10, 2024Break; Break
IT WAS REPORTED THAT THE PIN FROM THE AR-9207S SET BROKE OFF IN THE GUIDE.
Patient problems: Insufficient Information
MAUDE report 19286994 ↗
Other INSTRUMENT, MANUAL, SURGICAL, GENERAL USE devices
- Arthrex® AR-13995NArthrex, Inc. · INSTRUMENT, MANUAL, SURGICAL, GENERAL USE430 reports
- Arthrex® AR-12990NArthrex, Inc. · INSTRUMENT, MANUAL, SURGICAL, GENERAL USE197 reports
- Arthrex® AR-13991NArthrex, Inc. · INSTRUMENT, MANUAL, SURGICAL, GENERAL USE128 reports
- Arthrex® AR-8981-08SArthrex, Inc. · INSTRUMENT, MANUAL, SURGICAL, GENERAL USE1 recall3 reports
- Arthrex® AR-8981-06SArthrex, Inc. · INSTRUMENT, MANUAL, SURGICAL, GENERAL USE1 recall1 report
- HarmonyAIR LAS0042Steris Corporation · INSTRUMENT, MANUAL, SURGICAL, GENERAL USE1 recall0 reports
- Centurion EB16Centurion Medical Products Corporation · INSTRUMENT, MANUAL, SURGICAL, GENERAL USE1 recall0 reports
- Centurion Medical Products Corp SUT15830AMedline Industries, Inc. · INSTRUMENT, MANUAL, SURGICAL, GENERAL USE1 recall0 reports
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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