ACUFEX 7207602Recalls & reported problems
Smith & Nephew, Inc. · PUNCH TEARDROP LEFT · 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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03596010427359), received between Dec 6, 2022 and Dec 6, 2022 — classified as 1 malfunction.
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.
Most reported problems
Device problems
- Break1
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.
MalfunctionDec 6, 2022Break; Break
IT WAS REPORTED THAT DURING AN ARTHROSCOPY, WHEN ENTERING THE SITE THROUGH THE WORKING ACCESS WITH THE TEARDROP MICROPUNCH CLOSED, WHEN OPENING THE DEVICE, THE PART OF THE ANTERIOR PIECE BROKE OFF, WITHOUT THE FORCEPS TOUCHING THE TISSUE. THE DEVICE DID NOT TOUCH THE PATIENT. THE PROCEDURE WAS COMPLETED WITH BACK-UP DEVICE, AND NO DELAY WAS REPORTED. NO FURTHER COMPLICATIONS WERE REPORTED. THE CURRENT STATUS OF THE PATIENT IS GOOD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15929342 ↗
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- 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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