ACUFEX 7205519Recalls & reported problems
Smith & Nephew, Inc. · ACUFEX DIRECTOR ACL TIP 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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03596010373281), received between Jan 8, 2020 and Nov 1, 2020 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Failure to Align” (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 16, 2026.
Most reported problems
Device problems
- Failure to Align2
- Material Twisted/Bent1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Known Impact Or Consequence To Patient1
- No Patient Involvement1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 1, 2020Failure to Align; Material Twisted/Bent; Failure to Align; Material Twisted/Bent
IT WAS REPORTED THAT DURING THE SET UP BEFORE THE SURGERY, IT WAS NOTICED AN INACCURACY OF THE TIBIA TIP AIMER, 4-POINT BULLET AND ACUFEX TIBIA TIP AIMER HAVE BEEN ALL SET UP, 2.4MM GUIDE PIN WAS USED AND IT WAS NOTICED THAT THE EXIT OF THE GUIDE DID NOT HIT THE TIP OF THE AIMER, IT SLIGHTLY DEVIATED TO THE TIP. NO PATIENT INJURIES OR DELAY REPORTED. SMITH AND NEPHEW BACK-UP DEVICE WAS USED TO COMPLETE THE SURGERY. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement
MAUDE report 10767702 ↗MalfunctionJan 8, 2020Failure to Align; Failure to Align
IT WAS REPORTED THAT DURING AN ACL SURGERY, THE ACUFEX DRILL GUIDE WAS NOT LINED UP. THERE WAS NOT A BACK-UP AVAILABLE AND IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. THERE WAS NO DELAY AND NO PATIENT INJURIES REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9565610 ↗
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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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