Arthrex® AR-13960SRRecalls & reported problems
Arthrex, Inc. · ROTATOR CUFF GRASPER W/SR HANDLE · 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 00888867015746), received between Jun 7, 2024 and Jun 11, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Corroded” (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
- Corroded2
Patient problems
- Insufficient Information2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 11, 2024Corroded; Corroded
ON 05/13/2024 IT WAS REPORTED BY A DISTRIBUTOR VIA (B)(4) THAT AN AR-13960SR ROTATOR CUFF GRASPER W/SR HANDLE WAS RUSTED AND WOULD NOT CUT. THIS OCCURRED DURING USE. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Insufficient Information
MAUDE report 19508710 ↗MalfunctionJun 7, 2024Corroded; Corroded
ON 05/13/2024, IT WAS REPORTED BY A DISTRIBUTOR VIA (B)(4) THAT AN AR-13960SR ROTATOR CUFF GRASPER W/SR HANDLE WAS RUSTED AN WOULD NOT CUT. THIS OCCURRED DURING USE. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Insufficient Information
MAUDE report 19485365 ↗
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- FirstPass 72290129Smith & Nephew, Inc. · Accessories, arthroscopic82 reports
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- 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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