ACUFEX 72201732Recalls & reported problems
Smith & Nephew, Inc. · UNIVERSAL ENDOFEMORAL AIMER 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03596010608239), received between Mar 30, 2020 and Dec 9, 2025 — classified as 1 injury, 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.
Reports received per month
Most reported problems
Device problems
- Break1
- Flaked1
Patient problems
- Injury1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 9, 2025Break; Break
IT WAS REPORTED THAT, DURING AN ACL PROCEDURE, A HANDLE UNIVERSAL ENDOFEMORAL AIMER BROKE. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, WITH THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23761254 ↗InjuryMar 30, 2020Flaked; Flaked
IT WAS REPORTED THAT, DURING AN ACL RECONSTRUCTION, METAL SHEDDINGS WERE SEEN COMING OFF IN THE JOINT. THIS WAS NOTICED IN THE FEMORAL TUNNEL WHILE THE UNIVERSAL HANDLE WAS IN CONTACT WITH THE PASSING PIN. MOST OF THE METAL SHEDDINGS WERE REMOVED FROM THE KNEE JOINT WITH A MECHANICAL SHAVER. THE PROCEDURE WAS COMPLETED WITH THE SAME UNIVERSAL HANDLE. THERE WAS NO SIGNIFICANT DELAY REPORTED. THE PATIENT'S OUTCOME IS AS EXPECTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.
Patient problems: Injury
MAUDE report 9901355 ↗
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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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