ACUFEX 010600Recalls & reported problems
Smith & Nephew, Inc. · DISPOSABLE KNIFE HOOK STRAIGHT 3.0 MM BOX OF 5 · Class 1
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03596010032607), received between Nov 18, 2019 and Aug 21, 2023 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Material Separation” (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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Material Separation1
Patient problems
- Foreign Body In Patient1
- Neuropathy1
- Paresthesia1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryAug 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT ON LITERATURE REVIEW PERCUTANEOUS ULTRASOUND-GUIDED CARPAL TUNNEL RELEASE: STUDY UPON CLINICAL EFFICACY AND SAFETY, 12 PATIENTS HAD MINIMAL PARESTHESIA AFTER A PERCUTANEOUS CARPA TUNNEL RELEASE PROCEDURE USING AN ACUFEX DEVICE. IT IS UNKNOWN HOW WERE THE EVENTS TREATED. PATIENTS OUTCOME IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Neuropathy; Paresthesia
MAUDE report 17591857 ↗MalfunctionNov 18, 2019Material Separation; Material Separation
IT WAS REPORTED THAT DURING THE A ENDOSCOPIC CARPAL TUNEL THE KNIVES CANNOT LONGER BE BENT. THEY ARE VERY RIGID AND THE BREAKAGES ARE FREQUENT, THIS REQUIRES THE USE OF SEVERAL KNIVES DURING A SINGLE PROCEDURE. NO PATIENT INJURIES OR DELAY REPORTED. BACK-UP DEVICE WAS AVAILABLE.
Patient problems: Foreign Body In Patient
MAUDE report 9336637 ↗
Other ACCESSORIES,ARTHROSCOPIC devices
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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