A&E Medical / Rotating Surgical Punches 080-271Recalls & 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
- 6
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10841291105121), received between Feb 8, 2022 and Jun 4, 2025 — classified as 6 malfunctions.
The most frequently reported specific device problem is “Packaging Problem” (4 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
- Packaging Problem4
- Device Contaminated During Manufacture or Shipping1
- Manufacturing, Packaging or Shipping Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions6
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 4, 2025Packaging Problem; Packaging Problem
IT WAS REPORTED DURING INSPECTION OF THE PRODUCTS; FOREIGN OBJECTS WERE FOUND WITHIN THE STERILE PACKAGING. THERE WAS NO PATIENT INVOLVEMENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22143250 ↗MalfunctionJun 4, 2025Packaging Problem; Packaging Problem
IT WAS REPORTED DURING INSPECTION OF THE PRODUCTS; FOREIGN OBJECTS WERE FOUND WITHIN THE STERILE PACKAGING. THERE WAS NO PATIENT INVOLVEMENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22143248 ↗MalfunctionJun 4, 2025Packaging Problem; Packaging Problem
IT WAS REPORTED DURING INSPECTION OF THE PRODUCTS; FOREIGN OBJECTS WERE FOUND WITHIN THE STERILE PACKAGING. THERE WAS NO PATIENT INVOLVEMENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22143244 ↗MalfunctionOct 28, 2024Packaging Problem; Packaging Problem
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20545551 ↗MalfunctionJan 2, 2024Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
IT WAS REPORTED THAT A FOREIGN SUBSTANCE WAS FOUND INSIDE THE PACKAGING DURING A PRODUCT INSPECTION. THERE WAS NO PATIENT INVOLVEMENT. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18431174 ↗MalfunctionFeb 8, 2022Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED THAT A NURSE FOUND A FOREIGN SUBSTANCE IN THE TYVEK SHEET PRIOR TO USE FOR SURGERY. SUBSEQUENTLY, ANOTHER SURGICAL PUNCH WAS USED TO COMPLETE THE PROCEDURE WITH NO DELAY IN PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13481078 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page