Arthrex® AR-3320-01Recalls & reported problems
Arthrex, Inc. · SHEATH,HF,TAP/FEN,1STPCK F/STORZ 4mm SCP · 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 00888867029477), received between Jul 20, 2022 and Jul 20, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Component Missing” (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
- Component Missing1
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.
MalfunctionJul 20, 2022Component Missing
IT WAS REPORTED THAT DURING ARTHROSCOPY, THE FOLLOWING WAS DISCOVERED DURING SURGERY, A SMALL SCREW ON THE SIDE AT THE TOP OF THE WORKING TUBE IS GONE. A SCREW THAT NORMALLY IS NOT BEING REMOVED DURING WASHING AND STERILIZATION. PATIENT UNDERWENT X-RAY TO ENSURE SCREW IS NOT IN PATIENT, WHICH IS NOT THE CASE. IT IS UNKNOWN WHETHER SCREW WAS MISSING AT THE START OF SURGERY, AS NURSE IS NOT AWARE OF THIS PART, AS THE SCREW IS USUALLY NOT REMOVED WHEN INSTRUMENTS UNPACKED.
Patient problems: Insufficient Information
MAUDE report 15064957 ↗
Other Accessories, arthroscopic devices
- Arthrex® AR-12990Arthrex, Inc. · Accessories, arthroscopic409 reports
- 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.
How reports and recalls are matched · Editorial policy · Report an error on this page