A&E Medical / Rotating Surgical Punches 080-501Recalls & reported problems
A & E Medical Corporation · Rotating Surgical Punches, 1 per pouch · Class 1
All models of A&E Medical / Rotating Surgical Punches (10)
Data updated Oct 18, 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 10841291105244), received between Dec 5, 2023 and Dec 12, 2023 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Contamination /Decontamination Problem” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Contamination /Decontamination Problem2
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.
MalfunctionDec 12, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem
IT WAS REPORTED THAT WHILE TESTING THE AORTIC PUNCH DURING SET UP FOR SURGERY, A SMALL PIECE OF PLASTIC FELL OUT OF THE END OF THE PUNCH. THE PUNCH AND PIECE OF PLASTIC WERE REMOVED FROM THE SET UP. THERE WAS NO PATIENT INVOLVEMENT. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18312046 ↗MalfunctionDec 5, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18267041 ↗
Other Punch, Surgical devices
- SIGMA LCS HIGH PERFORMANCE 9505-02-012Depuy Orthopaedics, Inc. · PUNCH, SURGICAL85 reports
- SIGMA LCS 9505-02-018Depuy Orthopaedics, Inc. · PUNCH, SURGICAL1 recall10 reports
- DJO SURGICAL 801-05-040Encore Medical, L.P. · PUNCH, SURGICAL1 recall7 reports
- SIGMA LCS 9505-02-017Depuy Orthopaedics, Inc. · PUNCH, SURGICAL1 recall1 report
- SIGMA LCS 9505-02-016Depuy Orthopaedics, Inc. · PUNCH, SURGICAL1 recall0 reports
- SIGMA LCS 9505-02-021Depuy Orthopaedics, Inc. · PUNCH, SURGICAL1 recall0 reports
- SIGMA LCS 9505-02-020Depuy Orthopaedics, Inc. · PUNCH, SURGICAL1 recall0 reports
- SIGMA HIGH PERFORMANCE 9505-02-047Depuy (Ireland) · PUNCH, SURGICAL33 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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