ACUFEX 013499Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03596010090850), received between Apr 9, 2019 and Nov 22, 2020 — classified as 1 injury, 1 malfunction.

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.

• InjuryNov 22, 2020Break; Break

  IT WAS REPORTED THAT 4 DAYS AFTER THE SURGERY WHERE A DRILL BIT WAS USED, IT WAS FOUND THAT THERE WERE PIECES LEFT OF THIS INSTRUMENT INSIDE THE PATIENT'S ANATOMY. 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: Foreign Body In Patient

  MAUDE report 10881658 ↗
• MalfunctionApr 9, 2019Break

  IT WAS REPORTED THAT DURING AN ACL RECONSTRUCTION AFTER A GUIDE WIRE WAS INSERTED INTO FEMORAL BONE, THE SURGEON USED THE OVER DRILLING TO MAKE THE FEMORAL TUNNEL, BUT IT WAS HARD TO DRILL. WHEN THE GUIDE WIRE WAS REINSERTED, THE GUIDE WIRE BROKE. NO BACK-UP DEVICE AVAILABLE AND IT IS UNKNOWN IF THERE WAS DELAY IN THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8495745 ↗