ACUFEX 72204040Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00885554037692), received between Sep 28, 2021 and Feb 29, 2024 — classified as 4 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 29, 2024Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT DURING SET UP, THE STERILE PACKAGE OF THE RETROGRADE DRILL WAS OPENED. THERE WAS A BACK-UP DEVICE AVAILABLE AND NO DELAY WAS REPORTED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18806825 ↗
• MalfunctionAug 22, 2022Break; Break

  IT WAS REPORTED THAT DURING A KNEE SCOPE, THE RETROGRADE DRILL WAS BARELY USED AND IT BROKE. SURGERY RESUMED AFTER A NON-SIGNIFICANT SURGICAL DELAY AND WAS COMPLETED WITH A SMITH AND NEPHEW BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15269785 ↗
• InjuryJul 4, 2022Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC PROCEDURE, WHEN DRILLING THE TIBIAL TUNNEL WITH THE 7MM RETROGRADE DRILL THE SURGEON NOTICED THAT THE DRILL WAS NOT PROGRESSING, WHEN HE REMOVED THE DRILL, IT WAS EVIDENCE THAT THE DRILL HEAD HAD COME LOOSE. THE BROKE PART WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14911680 ↗
• InjuryMay 20, 2022Break; Break

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGERY, THE RETROGRADE DRILL BROKE. NO DEVICE PARTS REMAINED INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A NON-SIGNIFICANT DELAY USING A BACK-UP DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14455630 ↗
• InjuryMar 29, 2022Break; Break

  IT WAS REPORTED THAT, DURING A KNEE SURGERY, THE PROXIMAL PORTION OF THE RETROGRADE DRILL BROKE. NO PIECES WERE LEFT INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A S+N BACK UP DEVICE. THERE WAS NO DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13935909 ↗
• InjuryMar 2, 2022Break; Break

  IT WAS REPORTED THAT, DURING A LIGAMENT SUTURE PROCEDURE, WHEN THE SURGEON WAS GOING TO MAKE THE FEMUR TUNNEL WITH THE ACUFEX TRUNAV DRILL, IT BROKE WHEN IT CAME INTO CONTACT WITH THE PATIENT'S FEMUR CORTEX. THE PIECES WERE TOTALLY REMOVED. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH A BACK-UP DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED, THE PATIENT'S HEALTH CONDITION IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13651004 ↗
• MalfunctionSep 28, 2021Break; Mechanical Jam; Break; Mechanical Jam

  IT WAS REPORTED THAT DURING AN ACL PROCEDURE, WHEN THE RETROGRADE DRL WAS DRILLING FORWARD, THE DRILL WAS VERY SHAKY AND THE DRILL PIN GOT STUCK. THE RETROGRADE DRL AND THE DRILL PIN WERE REMOVED FROM THE PATIENT, THE DRILL PIN WAS REMOVED FROM THE RETROGRADE DRL AND THE PROCESS WAS STARTED AGAIN. ON THE SECOND ATTEMPT, THE RETROGRADE DRL WAS ACTIVATED SO THAT THE RETROGRADE ¿TOOTH¿ WAS ENGAGED BUT WHEN THE RETROGRADE DRL WAS STARTED A METAL WIRE SEEMED TO PARTIALLY BREAK OFF THE DRILL. NO METAL OR COMPONENTS OF THE DRILL WERE OBSERVED TO HAVE FALLEN INTO THE PATIENT. THE SYSTEM WAS REMOVED FROM THE PATIENT AND NOT USED. THE PROCEDURE WAS COMPLETED WITHOUT SIGNIFICANT DELAY USING A BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12542791 ↗