ACUFEX 72201716Recalls & reported problems
Smith & Nephew, Inc. · 6 MM OFFSET ENDOFEMORAL AIMER · 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 03596010608215), received between Mar 29, 2019 and Oct 4, 2022 — 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.
Most reported problems
Device problems
- Break1
- Mechanical Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryOct 4, 2022Break; Break
IT WAS REPORTED THAT, DURING AN ACL PROCEDURE, WHEN POSITIONING THE AIMER ENDOFEMORAL, THE SURGEON MADE A MOVEMENT THAT BROKE THE TIP OF THE GUIDE. IT WAS COMPLETELY REMOVED FROM THE PATIENT WITH GRASPER FORCEPS. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED, AND WHETHER IT CAUSED OR NOT A SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15536401 ↗MalfunctionMar 29, 2019Mechanical Problem
IT WAS REPORTED THAT DURING AN ACL PROCEDURE, IT WAS IMPOSSIBLE TO CLIP THE FEMORAL AIMER ON THE SIDE HOLE. THERE WAS NO SURGICAL DELAY OR PATIENT INJURIES BUT IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED SINCE NO BACKUP DEVICE WAS AVAILABLE. THE COMPLAINANT DOES NOT HAVE FURTHER INFORMATION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8462959 ↗
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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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