ACUFEX 72204043Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00885554037722), received between Jan 21, 2021 and Feb 9, 2026 — classified as 6 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Break” (8 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 9, 2026Break; Mechanical Jam

  IT WAS REPORTED THAT, DURING AN ACL SURGERY, THE BLADE OF ONE (1) ACUFEX TRUNAV RETROGRADE DRILL COULD NOT ROTATE BECAUSE IT HAD A BROKEN PART. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A SIMILAR S+N BACK-UP PRODUCT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24298953 ↗
• MalfunctionJul 21, 2025Break; Break

  IT WAS REPORTED THAT DURING A KNEE PROCEDURE, THE 8.5MM RETROGRADE DRILL BROKE OFF INSIDE THE KNEE, A FRAGMENT FELL INTO THE JOINT AND WAS REMOVED USING ARTHROSCOPY TWEEZERS, THE PROCEDURE WAS COMPLETED USING A S+N BACKUP DEVICE WITH A SURGICAL DELAY OF 15 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22562318 ↗
• MalfunctionAug 14, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE RETROGRADE 8.5 DRILL BIT BROKE WHEN ACTIVATING THE HELIX INSIDE THE FEMORAL TUNNEL SINCE THE DOCTOR DID NOT FOLLOW THE INSTRUCTIONS CORRECTLY. NO PART WAS LEFT INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A SURGICAL DELAY OF LESS THAN 30 MINUTES USING A SMITH AND NEPHEW BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19981245 ↗
• MalfunctionApr 30, 2024Break; Break

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE TRUNAV RETROGRADE DRILL BROKE AT THE LEVEL OF THE TIBIA, AFTER BEING USED CORRECTLY IN THE FEMUR. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A DELAY OF LESS THAN 30 MINUTES USING A SMITH AND NEPHEW BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19215766 ↗
• MalfunctionApr 1, 2024Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT DURING A POSTERIOR CRUCIATE LIGAMENT RECONSTRUCTION SURGERY, WHEN DRILLING WITH TWO RETROGRADE DRILLS, THE DISTAL CUTTING HEAD PROTRUDED AND STOPPED WORKING, IT WAS UNABLE TO MOVE IN OR OUT. THE DEVICES WERE REMOVED THROUGH FORCEFUL MEASURES. THE PROCEDURE WAS COMPLETED CHANGING THE SURGICAL APPROACH FROM AN ALL-INSIDE TECHNIQUE TO A CONVENTIONAL TECHNIQUE. THERE WAS A DELAY GREATER THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19011826 ↗
• InjuryNov 10, 2022Break; Break

  IT WAS REPORTED THAT DURING AN ACL PROCEDURE, THE DOCTOR DID NOT FOLLOW THE INSTRUCTIONS FOR USE OF THE RETROGRADE DRILL ACCORDING TO THE TECHNIQUE TO MAKE THE TUNNEL AND THE DEVICE BROKE; THERE WAS DIFFICULTY IN INSERTING THE INSERT AND FIXING THE ULTRABUTTON DEVICE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO DELAY USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15770399 ↗
• InjurySep 9, 2022Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY PROCEDURE, THE ACUFEX RETROGRADE DRILL WAS WORKING WELL ON FEMUR TUNNEL PREPARATION BUT DURING THE TIBIAL TUNNEL PREPARATION, THE TIP OF THE DRILL BROKE AND GOT STUCK INSIDE THE TIBIAL TUNNEL. THE BROKEN PIECE WAS THEN REMOVED MANUALLY USING A GRASPER. THE PROCEDURE WAS COMPLETED WITH A NON-SIGNIFICANT SURGICAL DELAY USING A BACK-UP DEVICE IN THE ORIGINALLY DRILLED BONE HOLE. NO FURTHER COMPLICATIONS WERE REPORTED. THE PATIENT CURRENT STATUS IS OK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15397338 ↗
• InjuryDec 14, 2021Break; Break

  IT WAS REPORTED THAT DURING AN ACL PROCEDURE, WHILE TRYING TO REAM THROUGH TIBIAL BONE, THE RETROGRADE DRILL MECHANISM THAT RETRACTS AND OPENS THE RETROGRADE BLADE BROKE UPON RESISTANCE FROM THE HARD TIBIAL BONE. THIS OCCURRED WITH TWO DRILLS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NON-SIGNIFICANT DELAY USING A S+N BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13003764 ↗
• InjuryMar 2, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, USING THE ACUFEX TRUNAV RETROGRADE DRILL, 8.5MM THE BLADE DID NOT DEPLOY IN JOINT SPACE. SAME EPISODE HAPPENED TO A 8.5MM DRILL REPLACEMENT. THE PROCEDURE WAS COMPLETED WITH A DELAY OF 30 MINUTES. SURGERY HAD TO BE COMPLETED WITH A 9MM DRILL. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED. RESULTS OF INVESTIGATION HAVE CONCLUDED THAT THIS DEVICE HAD DEBRIS WITHIN THE DRILL TIP AND CUTTER WHICH MAKES IT A REPORTABLE EVENT. 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 11399576 ↗
• InjuryJan 25, 2021Break; Break

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY, THE RETROGRADE DRILLS BROKE WHEN THE SURGEON TRIED TO DOWNSHIFT TO PIERCE THE TUNNEL IN THE FEMUR. THE PROCEDURE WAS COMPLETED WITHOUT 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 11221309 ↗
• InjuryJan 21, 2021Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, USING THE ACUFEX TRUNAV RETROGRADE DRILL, 8.5MM THE BLADE DID NOT DEPLOY IN JOINT SPACE. SAME EPISODE HAPPENED TO A 8.5MM DRILL REPLACEMENT. THE PROCEDURE WAS COMPLETED WITH A DELAY OF 30 MINUTES. SURGERY HAD TO BE COMPLETED WITH A 9MM DRILL. 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 11206228 ↗