Arthrex® AR-3373-5002Recalls & reported problems
Arthrex, Inc. · SHEATH,HF,TAP/FEN,2 STPCK F/4.8MM SCOPE · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00888867206984), received between Aug 24, 2020 and Aug 22, 2024 — classified as 1 injury, 3 malfunctions.
The most frequently reported specific device problem is “Break” (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.
Reports received per month
Most reported problems
Device problems
- Break1
- Crack1
- Defective Device1
- Detachment of Device or Device Component1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Device Embedded In Tissue or Plaque1
- Insufficient Information1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 22, 2024Crack; Crack
ON (B)(6)2024 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN (B)(4). SHEATH HAD A CRACK, AND IT WAS BENT. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20042522 ↗MalfunctionNov 21, 2023Defective Device; Defective Device
ON 10/24/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-3373-5002 SHEATH IS DAMAGED NON-SPECIFICALLY. THIS WAS DISCOVERED DURING USE WITH NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18182026 ↗MalfunctionAug 25, 2021Break
IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY PERFORMED ON (B)(6) 2021, THE SHEATH BROKE. THERE WERE NO FRAGMENTS REPORTED, AND THE PROCEDURE WAS COMPLETED USING A NEW DEVICE OF THE SAME PART NUMBER.
Patient problems: Insufficient Information
MAUDE report 12364441 ↗InjuryAug 24, 2020Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY THE TIP OF THE DEVICE BROKE OFF. THE SURGEON DECIDED TO NOT REMOVE THE FRAGMENT AS REMOVING THE TIP WOULD CAUSE MORE RISK TO THE PATIENT. THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE SAME DEVICE ANYWAY. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 10443186 ↗
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.
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