ACUFEX 7205517Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 03596010373250), received between Feb 13, 2019 and Mar 18, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 18, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, INSTRUMENTS OUTSIDE THE PATIENT, THE THREAD ON THE SCREW OF THE ACUFEX DIRECTOR DRILL GUIDE FUSED AND BROKE (THE SCREW HEAD BROKE). THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A SURGICAL DELAY OF LESS THAN 30 MINUTES USING THE SAME FAULTY DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21628260 ↗
• MalfunctionDec 17, 2020Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT THE ARROW ON THE ACL HANDLE HAS WORN OFF AND IT IS NO LONGER LEGIBLE; THEREFORE, IT IS IMPOSSIBLE TO SET THE ANGLE OF THE AIMER ACCURATELY. THE MALFUNCTION WAS FOUND DURING SET UP AND WAS SOLVED WITH NO DELAYS OR PATIENT HARM USING A BACK UP DEVICE. 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 11026659 ↗
• MalfunctionNov 1, 2020Failure to Align; Material Twisted/Bent; Failure to Align; Material Twisted/Bent

  IT WAS REPORTED THAT DURING THE SET UP BEFORE THE SURGERY, IT WAS NOTICED AN INACCURACY OF THE TIBIA TIP AIMER, 4 POINT BULLET AND ACUFEX TIBIA TIP AIMER HAVE BEEN ALL SET UP, 2.4MM GUIDE PIN WAS USED AND IT WAS NOTICED THAT THE EXIT OF THE GUIDE DID NOT HIT THE TIP OF THE AIMER, IT SLIGHTLY DEVIATED TO THE TIP. NO PATIENT INJURIES OR DELAY REPORTED. SMITH AND NEPHEW BACK-UP DEVICE WAS AVAILABLE TO COMPLETE THE SURGERY. 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; No Patient Involvement

  MAUDE report 10767700 ↗
• MalfunctionFeb 13, 2019Defective Device

  IT WAS REPORTED THAT THE DEVICE WAS DEFECTIVE. PRIOR TO DRILLING THE TIBIAL TUNNEL, WE COULD NOT ASSEMBLE THE GUIDE DUE TO THE FACT THAT THE BULLET WAS NOT ABLE TO SLIDE INTO THE GUIDE HANDLE. THE PROCEDURE WAS COMPLETED WITH A COMPETITOR DEVICE. NO PATIENT INJURIES WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8336020 ↗