ACUFEX 7205524Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 03596010373267), received between Aug 3, 2017 and Apr 8, 2026 — classified as 2 injuries, 5 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. 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 8, 2026Failure to Align

  IT WAS REPORTED THAT, DURING A KNEE ARTHROSCOPY WITH MENISCAL SUTURE, WHEN USING THE DRILL BIT AND SLEEVE IT DID NOT PASS THROUGH ONE (1) ACUFEX DIRECTOR ANGLED BULLET. SURGEON HAD TO DRILL SEVERAL TIMES WITH THE GUIDE. THE PROCEDURE WAS PERFORMED, WITH A DELAY GREATER THAN 30 MIN, USING THE SAME DEVICE. ADDITIONAL ANESTHESIA WAS REQUIRED AS CONSEQUENCE OF THE SURGICAL PROLONGATION. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Perforation

  MAUDE report 24818285 ↗
• InjuryJan 8, 2021Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT DURING A CRUCIATE LIGAMENT RECONSTRUCTION, WHEN USING THE TOOLS, DEVICE WAS UNABLE TO CATCH THE GUIDER WHEN USING THE POSITIONER GUIDE HANDLE. THIS RESULT IN THE HANDLE FALLING OFF. THERE WAS CHANGE IN THE SURGICAL TECHNIQUE AND A SIGNIFICANT DELAY. NO FURTHER COMPLICATIONS REPORTED. 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 11140481 ↗
• MalfunctionJun 18, 2020Illegible Information; Illegible Information

  IT WAS REPORTED THE BLT ASSY ANGLED DIRECTOR ACL HAD THE CALIBRATION MARKS NO LONGER LEGIBLE. THERE IS NOT A CASE REPORTED BUT THIS HAS BEEN AN ONGOING ISSUE. 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 10168798 ↗
• MalfunctionJun 18, 2020Illegible Information; Illegible Information

  IT WAS REPORTED THE BLT ASSY ANGLED DIRECTOR ACL HAD THE CALIBRATION MARKS NO LONGER LEGIBLE. THERE IS NOT A CASE REPORTED BUT THIS HAS BEEN AN ONGOING ISSUE. 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 10168741 ↗
• InjuryMar 30, 2020Flaked; Flaked

  IT WAS REPORTED THAT, DURING AN ACL RECONSTRUCTION, METAL SHEDDINGS WERE SEEN COMING OFF IN THE JOINT. THIS WAS NOTICED IN THE FEMORAL TUNNEL WHILE THE AXCUFEX'S 2.4 MM BULLET GUIDE WAS IN CONTACT WITH THE PASSING PIN. MOST OF THE METAL SHEDDINGS WERE REMOVED FROM THE KNEE JOINT WITH A MECHANICAL SHAVER. THE PROCEDURE WAS COMPLETED WITH THE SAME BULLET GUIDE. THERE WAS NO SIGNIFICANT DELAY REPORTED. THE PATIENT'S OUTCOME IS AS EXPECTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Injury

  MAUDE report 9901437 ↗
• MalfunctionMay 27, 2018Break

  IT WAS REPORTED DURING A CRUCIATE LIGAMENT RECONSTRUCTION SURGERY, THE KIRSCHNER WIRE BROKE IN THE ANGLE DIRECTOR AND COULDN¿T BE PULLED OUT. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7547267 ↗
• MalfunctionAug 3, 2017Break

  IT WAS REPORTED THAT THE DEVICE BROKE WHILE USING IT TO TRY TO REMOVE A SCREW. NO BACKUP DEVICE WAS AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6762985 ↗