ACUFEX 7209491Recalls & reported problems
Smith & Nephew, Inc. · SCISSOR DOUBLE HOOK · Class 1
All models of ACUFEX (86)
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 03596010474551), received between Sep 5, 2021 and Nov 27, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (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
- Break2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 27, 2024Break; Break
IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE SCISSOR DOUBLE HOOK CLAMP WAS ALREADY DEFECTIVE, WHEN IT WAS INSERTED AND WHEN TRYING TO CUT, IT BROKE INSIDE THE PATIENT. THE BROKEN PIECES WERE REMOVED USING TWEEZERS. THE PROCEDURE WAS COMPLETED WITH A SMITH AND NEPHEW BACK UP DEVICE. THERE WAS A DELAY GREATER THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20797000 ↗MalfunctionSep 5, 2021Break; Break
IT WAS REPORTED THAT THE SCISSOR DOUBLE HOOK WAS BROKEN, IT CAME APART FROM THE SCISSOR END. IT IS UNKNOWN WHETHER THE EVENT HAPPENED DURING SURGERY AND IF THERE WAS PATIENT INVOLVEMENT. NO FURTHER DETAILS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12426592 ↗
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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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