ACUFEX 014723Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03596010026255), received between Jul 12, 2020 and Feb 15, 2021 — classified as 2 injuries.

The most frequently reported specific device problem is “Break” (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

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 15, 2021Break; Break

  IT WAS REPORTED THAT, DURING AN ACL AND PCL REPAIR PROCEDURE, WHEN THE "7.9MM SMOOTHER TOOL" PASSED, THE STEEL HOOK BROKE LEAVING NO SUPPORT TO PULL IT OUT OF THE JOINT AND GRAFT PASSAGE. THE GRAFT USED WAS HAMSTRING OF SIZE 9. THE BROKEN MATERIAL WAS REMOVED USING TWEEZERS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SIGNIFICANT DELAY USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11330047 ↗
• InjuryJul 12, 2020Break; Break

  IT WAS REPORTED THAT DURING A RECONSTRUCTION OF LCP, THE SMOOTHER STALLED IN THE TUNNELS AND WHEN IT WAS BEING TRYING TO REMOVE IT, THE PLASTIC PART OF TRACTION WAS BROKEN. THE PIECES WERE REMOVED FROM THE PATIENT WITH PLIERS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A SIGNIFICANT DELAY USING A BACK-UP DEVICE. NO OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Injury

  MAUDE report 10262201 ↗