ACUFEX 72204045Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00885554037746), received between Dec 22, 2020 and Jun 1, 2026 — classified as 4 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Break” (12 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 1, 2026Break

  IT WAS REPORTED THAT, DURING A MENISCUS TRANSPLANT SURGERY, THE DRILLING TIP OF THE RETROGRADE DRILL HAD SHEARED OFF DRILL SHAFT. DRILL TIP COULD NOT BE RETRIEVED AND REMAINED IN THE BONE. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT SN BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25355396 ↗
• MalfunctionOct 14, 2024Detachment of Device or Device Component; Material Deformation; Detachment of Device or Device Component; Material Deformation

  IT WAS REPORTED THAT, DURING A PROCEDURE, WHEN DRILLING THE BLADE PART OF THE ACUFEX RETROGRADE DRILL WAS DISLOCATED UNABLE TO BE RETRACTED BACK TO THE WINDOW. A GRASPER WAS USED TO FORCE THE BLADE TO RETRACT INTO ITS ORIGINAL SLOT AND WAS REMOVED FROM THE PATIENT. SURGERY WAS COMPLETED WITH A BACK-UP DEVICE INSTEAD. THERE WAS A DELAY OF LESS THAN 30 MINUTES, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20443953 ↗
• MalfunctionMar 11, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION, THE RETROGRADE DRILL CUTTING BLADES BROKE. THE DRILL WAS USED TO COMPLETE THE DRILLING TIBIA CORTEX OUT INTO THE JOINT, HOWEVER, THE TIP WAS FOUND TO BE BROKEN UPON TRYING TO FLIP THE RETROGRADE BLADE TO NO AVAIL. ALL THE BROKEN PIECES WERE RETRIEVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED USING A S+N BACK UP DEVICE. THERE WAS A DELAY OF LESS THAN 30 MINUTES NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18878755 ↗
• MalfunctionMar 11, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION, THE RETROGRADE DRILL CUTTING BLADES BROKE. THE DRILL BROKE DURING THE INITIAL DRILLING OF THE TIBIA. ALL THE BROKEN PIECES WERE RETRIEVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED USING A S+N BACK UP DEVICE. THERE WAS A DELAY OF LESS THAN 30 MINUTES. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18878611 ↗
• MalfunctionDec 6, 2023Break; Material Deformation; Insufficient Device Problem Information; Break; Material Deformation; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY, THE ACUFEX RETROGRADE DRILL'S BLADE WAS NOT WORKING CORRECTLY, NO MORE DETAILS ARE AVAILABLE. NO ADDITIONAL PATIENT INFORMATION IS AVAILABLE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A NON-SIGNIFICANT SURGICAL DELAY USING A SMITH AND NEPHEW BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED. THE RESULTS OF INVESTIGATION REVEALED THAT THE DEVICE´S OUTER SHAFT WITH DEPTH MARKINGS WAS FRACTURED AWAY FROM THE INNER SHAFT AND THE DISTAL END WAS DEFORMED AND TOTALLY CRIMPED OUT; AS WELL THE ACTUATOR WIRE WAS ATTACHED TO THE GREY SLIDER, HOWEVER THE ENTIRE DISTAL END IS MISSING AND IT HAS BIOLOGICAL DEBRIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18276023 ↗
• MalfunctionDec 6, 2023Break; Mechanical Jam; Break; Mechanical Jam

  IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY, THE ACUFEX RETROGRADE DRILL'S BLADE WAS NOT WORKING CORRECTLY, NO MORE DETAILS ARE AVAILABLE. NO ADDITIONAL PATIENT INFORMATION IS AVAILABLE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A NON-SIGNIFICANT SURGICAL DELAY USING A SMITH AND NEPHEW BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED. THE RESULTS OF INVESTIGATION REVEALED THE ENTIRE DISTAL END WAS FRACTURED AWAY AND RETURNED WITH THE DRILL GUIDE. ALSO ITS ACTUATOR WAS STUCK IN THE FULLY EXTENDED POSITION AND IT HAS BIOLOGICAL DEBRIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18275970 ↗
• InjuryNov 8, 2023Break; Break

  IT WAS REPORTED THAT DURING A TIBIAL RETROGRADE TUNNEL SURGERY, THE DISTAL END OF THE 9.5MM RETROGRADE DRILL BIT REMAINED IN THE TIBIAL TUNNEL, AND THE DRILL BIT WAS RECOVERED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITHOUT SURGICAL DELAY USING A S+N BACK UP DEVICE IN THE ORIGINALLY DRILLED BONE HOLE. ANTIBIOTIC THERAPY WAS STARTED, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18097445 ↗
• MalfunctionAug 30, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING A KNEE SCOPE, THE RETROGRADE DRILL DID NOT FUNCTION PROPERLY. THE SURGERY WAS RESUMED AFTER A SIGNIFICANT DELAY GREATER THAN 30 MINUTES USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17654617 ↗
• MalfunctionAug 29, 2023Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, WHEN DRILLING INTO THE JOINT WITH THE ACUFEX TRUNAV RETROGRADE DRILL 9MM, THE DRILL BIT SNAPPED OFF THE SHAFT, WITH ONLY THE FLIPPING WIRE CONNECTING THE DRILL BIT TO THE DEVICE WHEN BREAKING THE CORTEX. NON-SIGNIFICANT DELAY WAS REPORTED, AND THE PROCEDURE WAS FINISHED WITH A SMITH AND NEPHEW BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17646242 ↗
• InjuryOct 19, 2022Break; Break

  IT WAS REPORTED THAT DURING A LCA RUPTURE-LCA RECONSTRUCTION, AN ACUFEX TRUNAV RETROGRADE DRILL´S CUTTER BROKE THE CUTTING END INSIDE THE PATIENT´S FEMUR, REMAINING 1 CM DEEPER. SURGERY WAS RESUMED AFTER THE NECESSARY DELAY IN ORDER TO REMOVE THE BROKEN TIP OF THE BUR, WITH A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15632137 ↗
• InjuryFeb 11, 2022Break; Break

  IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY PROCEDURE, THE (B)(6) BLADE INSIDE THE RETROGRADE DRILL COULD NOT BE CLOSED, IT WAS STUCK. THE METAL PIECE BROKE INSIDE THE KNEE AND THE PIECE WAS RETRIEVED WITH A GRASPER. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NON-SIGNIFICANT DELAY USING A BACK-UP DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13518184 ↗
• InjuryNov 3, 2021Break; Misassembled; Material Split, Cut or Torn; Break; Misassembled; Material Split, Cut or Torn

  IT WAS REPORTED THAT, DURING RECONSTRUCTION OF THE ANTERIOR CRUCIATE LIGAMENT, INSIDE THE PATIENT, WHERE THE RETROGRADE DRL 9.5MM WAS USED, WHEN IT WAS BRAZING, IT WAS EVIDENCED THAT THE PART WHERE THE NUMBERS ARE WAS SPLIT AND THE PART THAT HELPS TO ROTATE THE ORANGE BASE OF THE DRILL WAS DETACHED AVOIDING THAT THIS COULD ROTATE. THE PIECES WERE RETIRED IN ITS TOTALITY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SIGNIFICANT DELAY USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12746782 ↗
• MalfunctionNov 1, 2021Break; Break

  IT WAS REPORTED THAT DURING USE IN AN ANTERIOR CRUCIATE LIGAMENT SURGERY, THE "RETROGRADE DRL" BROKE IN DURING THE DRILLING. THE PROCEDURE WAS COMPLETED WITH A DELAY GREATER THAN 30 MINUTES AND WAS FINISHED WITH A SMITH AND NEPHEW BACK UP DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12734202 ↗
• MalfunctionDec 22, 2020Break; Break

  IT WAS REPORTED THAT THE BLADE OF THE ACUFEX TRUNAV RETROGRADE DRILL WAS BROKEN / SEIZED INSIDE THE PATIENT. IT COULD NOT BE PICKED UP, SO THE "ALL INSIDE" TECHNIQUE COULD NOT BE DONE, AS A RESULT THE PROCESS WAS COMPLETED WITH A CHANGE IN TECHNIQUE AND THE FEMUR HAD TO BE COMPLETELY DRILLED. THERE WAS A DELAY OF LESS THAN OR EQUAL TO 30 MIN. NO 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 11055762 ↗