ACUFEX 72203169Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885554030518), received between Jul 12, 2020 and Jul 12, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Markings/Labelling Problem” (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

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 12, 2020Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT DURING AN ALL INSIDE ACL, IT WAS FOUND THAT THE 2.4MM DRILL WIRE INCLUDED IN THE TRUNAV SET WAS DEFECTIVE. THE LASER MARKING AT THE TIP OF THE DRILL WAS MISSING. WHEN POSITIONED THE DRILL APPROXIMATELY AS IT SHOULD HAVE BEEN WITH LASER MARKING AND WHEN THE ACUFEX WAS MOVED IN THE GAUGE OVER THE WIRE FROM THE OUTSIDE, THE GAUGE SHOWED A FEMORAL TUNNEL LENGTH OF 65MM, WHICH WAS CONSIDERED VERY UNLIKELY AND IT WAS NECESSARY TO USED ALTERNATIVE MEASUREMENT METHODS. THE PROCEDURE WAS COMPLETED WITHOUT 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: No Known Impact Or Consequence To Patient

  MAUDE report 10262180 ↗