ACUFEX 72201731Recalls & reported problems
Smith & Nephew, Inc. · STERILIZATION TRAY FOR ACUFEX DIRECTOR ELITE ACL DRILL GUIDE SYSTEM · Class 2
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03596010608178), received between Feb 26, 2021 and Feb 26, 2021 — classified as 3 injuries.
The most frequently reported specific device problem is “Failure to Align” (3 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
- Failure to Align3
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryFeb 26, 2021Failure to Align; Failure to Align
IT WAS REPORTED THAT, DURING AN ACL RECONSTRUCTION CASE, IT WAS FOUND THAT THE TIBIAL GUIDE WAS OFF TARGET. THIS TARGETING ISSUE RESULTED IN HAVING TO OPEN ANOTHER ACL TRAY WITH PROPER TIBIAL GUIDES TO ENSURE SUCCESS IN THE FORMATION AND ALIGNMENT FOR THE TIBIAL TUNNEL. 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
MAUDE report 11385544 ↗InjuryFeb 26, 2021Failure to Align; Failure to Align
IT WAS REPORTED THAT, DURING AN ACL RECONSTRUCTION CASE, IT WAS FOUND THAT THE TIBIAL GUIDE WAS OFF TARGET. THIS TARGETING ISSUE RESULTED IN HAVING TO OPEN ANOTHER ACL TRAY WITH PROPER TIBIAL GUIDES TO ENSURE SUCCESS IN THE FORMATION AND ALIGNMENT FOR THE TIBIAL TUNNEL. NO SIGNIFICANT DELAY OF FURTHER COMPLICATIONS WERE REPORTED. 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
MAUDE report 11385515 ↗InjuryFeb 26, 2021Failure to Align; Failure to Align
IT WAS REPORTED THAT, DURING AN ACL RECONSTRUCTION CASE, IT WAS FOUND THAT THE TIBIAL GUIDE WAS OFF TARGET. THIS TARGETING ISSUE RESULTED IN HAVING TO OPEN ANOTHER ACL TRAY WITH PROPER TIBIAL GUIDES TO ENSURE SUCCESS IN THE FORMATION AND ALIGNMENT FOR THE TIBIAL TUNNEL. NO SIGNIFICANT DELAY OF FURTHER COMPLICATIONS WERE REPORTED. 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
MAUDE report 11385489 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.