Arthrex® AR-13975NRRecalls & reported problems
Arthrex, Inc. · FIBERWIRE GRASPER W/ NR HANDLES · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867015821), received between Mar 21, 2022 and Mar 21, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Output Problem” (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.
Most reported problems
Device problems
- Output Problem1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 21, 2022Output Problem
ON 12/07/2021, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA SEMS THAT AN AR-13975NR IS NOT WORKING PROPERLY. THIS WAS DISCOVERED DURING USE IN A PROCEDURE. NO PATIENT AFFECT REPORTED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED. DURING RETURNED DEVICE EVALUATION, A REPORTABLE MALFUNCTION WAS DISCOVERED.
Patient problems: Insufficient Information
MAUDE report 13839506 ↗
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- NA 228302Medos International Sàrl · ACCESSORIES,ARTHROSCOPIC287 reports
- FIRSTPASS 72290128Smith & Nephew, Inc. · ACCESSORIES,ARTHROSCOPIC232 reports
- NA 251723Medos International Sàrl · ACCESSORIES,ARTHROSCOPIC145 reports
- COBRA 3910900093Stryker Corporation · Accessories, arthroscopic138 reports
- FirstPass 72290129Smith & Nephew, Inc. · Accessories, arthroscopic82 reports
- FirstPass 72290130Smith & Nephew, Inc. · Accessories, arthroscopic80 reports
- MITEK 242025Medos International Sàrl · ACCESSORIES,ARTHROSCOPIC61 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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