ACUFEX 7207201Recalls & reported problems
Smith & Nephew, Inc. · PUNCH OVAL STRAIGHT · Class 1
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 03596010253521), received between Nov 8, 2020 and Nov 10, 2021 — classified as 4 injuries.
The most frequently reported specific device problem is “Break” (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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Break4
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- No Code Available1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryNov 10, 2021Break; Break
IT WAS REPORTED THAT DURING ACL PROCEDURE, INTERNAL TO PATIENT, THE ACUFEX CUTTER HAD A BROKEN BRANCH, ALL THE BROKEN PIECES WERE REMOVED USING FORCEPS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A S+N BACK-UP DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12788698 ↗InjuryNov 10, 2021Break; Break
IT WAS REPORTED THAT DURING AN ACL PROCEDURE, THE PUNCH OVAL STR HAD A BROKEN BRANCH. BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE. NO DELAY AND NO PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12786107 ↗InjuryNov 9, 2021Break; Break
IT WAS REPORTED THAT, DURING AN ARTHROSCOPY, THE ACUFEX OVAL PUNCH HAD A BROKEN BRANCH. IT IS UNKNOWN IF THE INSTRUMENTS WERE INSIDE OR OUTSIDE PATIENT. THE PROCEDURE WAS COMPLETED WITH A S+N BACK UP DEVICE. NO DELAY AND NO PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12782565 ↗InjuryNov 8, 2020Break; Break
IT WAS REPORTED THAT DURING SURGERY, WHEN THE MENISCUS WAS BEING REPAIRED WITH THE PUNCH, THE PUNCH HEAD BROKE AND WAS STUCK IN THE POSTERIOR CORNER OF THE PATIENT'S KNEE JOINT CAVITY. THE BROKEN PIECE WAS REMOVED WITH OTHER INSTRUMENTS. IT IS UNKNOWN IF THE PROCEDURE WAS SUCCESSFULLY COMPLETED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.
Patient problems: No Code Available; No Consequences Or Impact To Patient
MAUDE report 10807098 ↗
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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