ACUFEX 72204049Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885554037784), received between Sep 17, 2020 and Oct 20, 2023 — classified as 2 malfunctions.

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. How this data works · Data updated Oct 13, 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.

• MalfunctionOct 20, 2023Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING AN ACL SURGERY, AFTER RETROGRADE DRILLING THE FEMORAL TUNNEL WITH THE TRUNAV, THE BLADE COULD NOT BE PROPERLY RETRIEVED BACK. THE BLADE WAS STUCK AND IN ORDER TO RETRIEVE THE TRUNAV, THE BLADE HAD TO BE FORCIBLY BROKEN, THE BROKEN PIECES WERE RETRIEVED,. THE PROCEDURE WAS COMPLETED WITH A DELAY GREATER THAN 30 MIN USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17976561 ↗
• MalfunctionSep 17, 2020Break; Break

  IT WAS REPORTED THAT THE DURING PROCEDURE, THE PRODUCT BROKE INSIDE THE PATIENT. NO DELAY AND IT IS UNKNOWN IF THERE WAS A BACK UP INVOLVED. 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: No Information

  MAUDE report 10548856 ↗