ACUFEX 010912Recalls & reported problems
Smith & Nephew, Inc. · PUNCH BASKET ROTARY 90 DEGREE 2.2 MM LEFT LOOP HANDLE · 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 03596010022776), received between Feb 5, 2019 and Sep 19, 2024 — classified as 2 malfunctions.
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.
Reports received per month
Most reported problems
Device problems
- Difficult to Open or Close1
- Insufficient Device Problem Information1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 19, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE ROTARY PUNCH HANDLE OF THE PUNCH BASKET MALFUNCTIONED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A SURGICAL DELAY GREATER THAN 30 MINUTES USING A SMITH AND NEPHEW BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20257253 ↗MalfunctionFeb 5, 2019Difficult to Open or Close
IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY THE DEVICE DID NOT OPEN. THE PROCEDURE WAS COMPLETED WITH ANOTHER SIMILAR DEVICE. NO SIGNIFICANT DELAY OR PATIENT INJURY REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8307854 ↗
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- NA 251723Medos International Sàrl · ACCESSORIES,ARTHROSCOPIC145 reports
- COBRA 3910900093Stryker Corporation · Accessories, arthroscopic138 reports
- FirstPass 72290129Smith & Nephew, Inc. · Accessories, arthroscopic82 reports
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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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