ACUFEX 72201717Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03596010608222), received between Apr 2, 2019 and May 18, 2026 — classified as 3 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 18, 2026Break

  IT WAS REPORTED THAT, DURING AN ACL PROCEDURE, AN ENDOFEMORAL AIMER BROKE IN HALF. ALL PIECES WERE RETRIEVED USING A GRASPER. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT SURGICAL DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25203587 ↗
• MalfunctionNov 4, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT DURING A PROCEDURE, THE ENDO FEMORAL AIMER BROKE FROM THE HANDLE. THERE WAS NO DELAY OR PATIENT INJURIES REPORTED BUT IT IS UNKNOWN IF A BACKUP WAS AVAILABLE TO COMPLETE THE PROCEDURE. 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 9272710 ↗
• MalfunctionApr 2, 2019Corroded

  IT WAS REPORTED THAT THE AIMER WAS RUST. NO PATIENT INJURIES OR DELAY WERE REPORTED AS THE FAILURE WAS FOUND AFTER THE SURGERY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8476021 ↗