ACUFEX 012030Recalls & reported problems
Smith & Nephew, Inc. · PUNCH BASKET SCOOP UPBITER 1.3MM LOOP HANDLE · Class 1
All models of ACUFEX (86)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03596010023551), received between Dec 2, 2022 and Dec 2, 2022 — classified as 1 injury.
The most frequently reported specific device problem is “Difficult to Open or Close” (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
- Difficult to Open or Close1
- Flaked1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryDec 2, 2022Flaked; Difficult to Open or Close; Flaked; Difficult to Open or Close
IT WAS REPORTED THAT DURING A KNEE SCOPE, THE PUNCH FAILED TO PERFORMED AS EXPECTED. IT IS UNKNOWN IF THE DEVICE WOULD NOT BITE THROUGH TISSUE OR IT WAS DIFFICULT TO OPEN AND CLOSE AND WAS SHEDDING METAL. THE PROCEDURE WAS COMPLETED WITH A S+N BACK UP DEVICE. THERE WAS A NON-SIGNIFICANT SURGICAL DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15901916 ↗
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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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