ACUFEX 72201715Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 03596010608208), received between Mar 29, 2019 and Dec 26, 2023 — classified as 3 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Break” (4 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.

• MalfunctionDec 26, 2023Break; Break

  IT WAS REPORTED THAT DURING AN ACL RECONSTRUCTION SURGERY, THE TIP OF THE 5MM ENDOFEMORAL AIMER BROKE WHEN PLACING THE GUIDE WITH A LITTLE FORCE. THE BROKEN PIECES WERE COMPLETED REMOVED. THE PROCEDURE WAS COMPLETED WITH A S+N BACK UP DEVICE. THERE WAS NO SURGICAL DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18395099 ↗
• InjuryOct 18, 2021Break; Break

  IT WAS REPORTED THAT, THE TOP OF THE AIMER ENDOFEMORAL 5MM OFFSET (RED) BROKE, INSIDE THE PATIENT, DURING ARTHROSCOPY PROCEDURE. IT WAS REMOVED WITH GRASPER TIP. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY BUT IT IS UNKNOWN IF A BACKUP DEVICE WAS AVAILABLE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12647973 ↗
• InjuryMay 19, 2021Break; Break

  IT WAS REPORTED THAT DURING A PROCEDURE, WHEN STARTING THE PROCEDURE OF DRILLING THE FEMUR, THE TRANSTIBIAL GUIDE WAS INSERTED IN THE LATERAL CONDYLE, WHEN BENDING THE PATIENT'S LEG THE TIP OF THE GUIDE BROKE AND IT WAS NOT FOUND SEEN ONLY IN X-RAY. THE DOCTOR CHOSE NOT TO REMOVE THE FRAGMENT AS IT WAS ATTACHED TO THE PATIENT'S BONE. NO DELAY WAS REPORTED, AND NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 11850344 ↗
• 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 OFFSET 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 OFFSET 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 9901389 ↗
• MalfunctionDec 26, 2019Crack; Flaked; Crack; Flaked

  IT WAS REPORTED THAT DURING AN ACL RECONSTRUCTION, WHEN THE PASSING PIN WAS PASSED THROUGH THE ENDOFEMORAL AIMER, A SIGNIFICANT AMOUNT OF SWARF CAME OFF. ON INSPECTION, IT WAS NOTICED THAT THE AIMER HAD A SMALL GROOVE AT THE DISTAL TIP. ALL THE MATERIAL WAS REMOVED USING SUCTION FROM SHAVER AND A LAVAGE OF THE KNEE WAS PERFORMED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT A SIGNIFICANT DELAY USING A BACK-UP DEVICE. NO PATIENT INJURY OR 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 9519955 ↗
• MalfunctionApr 16, 2019Break

  IT WAS REPORTED THAT DURING SURGERY THE POINT OF THE WIRE BROKE DURING THE PASSAGE IN THE BONE. IT IS UNKNOWN IF A BACK UP DEVICE WAS AVAILABLE OR IF A DELAY WAS CAUSED BY THE DEVICE MALFUNCTION, BUT NO PATIENT INJURIES WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8519611 ↗
• MalfunctionMar 29, 2019Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT DURING AN ACL PROCEDURE, IT WAS IMPOSSIBLE TO CLIP THE FEMORAL AIMER ON THE SIDE HOLE. THERE WAS NO SURGICAL DELAY OR PATIENT INJURIES BUT IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED SINCE NO BACKUP DEVICE WAS AVAILABLE. THE COMPLAINANT DOES NOT HAVE FURTHER INFORMATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8462958 ↗