ACUFEX 72204044Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 00885554037739), received between Jul 14, 2020 and Jun 20, 2026 — classified as 9 injuries, 16 malfunctions.

The most frequently reported specific device problem is “Break” (18 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 25 most recent of 25 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 20, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING AN ACL RECONSTRUCTION, WHEN ONE (1) RETROGRADE DRL 9MM WAS INSERTED INTO THE TIBIA TO CREATE THE TUNNEL, WHILE INSIDE OF THE JOINT, THE WING WAS ATTEMPTED TO BE OPENED, IT DETACHED FROM THE RETROGRADE DRL 9MM. THE PIECES WERE COMPLETELY REMOVED USING ARTHROSCOPIC FORCEPS. 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 25570304 ↗
• MalfunctionFeb 27, 2026Break; Positioning Failure

  IT WAS REPORTED THAT DURING A KNEE ARTROSCOPY AND LCA MENISCUS SUTURE, THE RETROGRADE DRILL DID NOT OPEN AND IMMEDIATELY BROKE. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT SN BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24477396 ↗
• MalfunctionFeb 14, 2026Break

  IT WAS REPORTED THAT DURING A PROCEDURE, THE RETROGRADE DRILL GUIDE WIRE WAS USED FOR PASSING AND IT BROKE IN HALF. IT IS UNKNOWN HOW THE PROCEDURE WAS PERFORMED OR IF THERE WAS A DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24341332 ↗
• MalfunctionFeb 4, 2026Break

  IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY, THE SHAFT OF THE 9MM ACUFEX RETROGRADED DRILL BROKE INSIDE WHILE CREATING THE TUNNEL. THE BROKEN PIECE WAS REMOVED FROM INSIDE THE PATIENT USING A HOLE PUNCHER. 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 24259981 ↗
• MalfunctionNov 10, 2025Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  IT WAS REPORTED THAT, DURING AN ANTERIOR CRUCIATE LIGAMENT PROCEDURE, WHEN TRYING TO OPEN THE RETROGRADE BLADE, IT WAS BLOCKED AND THE BLADE REMAINED PARTIALLY OPEN, AND WHEN FORCING IT OPEN, IT BROKE THE MECHANISM. THE PROCEDURE WAS RESUMED, WITH A NON SIGNIFICANT DELAY, USING A SIMILAR S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23518462 ↗
• MalfunctionOct 6, 2025Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING AN ACL RECONSTRUCTION, IT WAS NOTICED THAT WHEN THE SURGEON ATTEMPTED TO DISCONNECT A RETROGRADE DRILL FROM THE CHUCK, THEY REMOVED THE GUIDE THEN PREPARED TO PASS THE NITINOL WIRE LOOP INTO THE JOINT, THE DRILL COULD NOT BE REMOVED FOR NO APPARENT REASON AND ITS COMPONENTS BROKE OFF. THE SURGEON THEN REMOVED THE NITINOL WIRE AND CONFIRMED THAT ALL BROKEN PIECES OF THE DRILL WERE RETRIEVED, AS THEY WERE EXTERNAL TO THE PATIENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK-UP. A NEW RETROGRADE DRILL WAS OPENED TO OBTAIN ANOTHER NITINOL LOOP, AS THE ORIGINAL NITINOL WIRE WAS BENT DURING THE DETACHMENT OF THE DRILL COMPONENTS. USING THE NEW NITINOL WIRE, THE SURGEON WAS ABLE TO PASS IT THROUGH THE EXISTING CANNULATION OF THE DRILL AND SUBSEQUENTLY REMOVE THE DRILL FROM THE NITINOL WIRE WITHOUT FURTHER ISSUE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23221424 ↗
• MalfunctionJan 5, 2025Break; Break

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE TRUNAV RETROGRADE 9MM DRILL BIT WAS MOUNTED ON THE MOTOR AND DURING USE IT BROKE IN THE MOTOR ADAPTER AREA, PREVENTING THE BLADE FROM FIRING FOR 9MM DRILLING. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A SURGICAL DELAY GREATER 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 21076657 ↗
• MalfunctionNov 22, 2024Break; Break

  IT WAS REPORTED THAT DURING SURGERY, THE ACUFEX TRUNAV RETROGRADE DRILL CUTTER BROKE. THE PROCEDURE WAS COMPLETED WITH A SURGICAL DELAY GREATER 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 20761665 ↗
• MalfunctionJun 17, 2024Break; Break

  IT WAS REPORTED THAT DURING A LCA PROCEDURE, WHILE USING THE RETROGRADE DRILL WHEN ADVANCED TO ASSEMBLE THE DRILL IT DID NOT WORK, BREAKING ALONG THE WAY. THE PROCEDURE WAS COMPLETED WITHOUT SURGICAL DELAY USING A RETROGRADE DRL 8MM AS BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19554823 ↗
• MalfunctionSep 14, 2023Break; Break

  IT WAS REPORTED THAT DURING AN ACL, THE ACUFEX TRUNAV RETROGRADE DRILL BROKE NEAR A SCREW LOCATED PROXIMALLY TO THE SURGEON. THE DRILL COULD NO LONGER DRILL, AS IT DID NOT TURN. A BACK UP DRILL WAS OPENED AND USE TO MAKE THE HOLE TO PLACE THE GRAFT. THE PROCEDURE WAS COMPLETED, AND NO DELAY WAS REPORTED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17749085 ↗
• MalfunctionAug 28, 2023Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY, THE RETROGRADE BLADE WAS NOT DEPLOYED. THE PROCEDURE WAS COMPLETED WITH A DELAY GREATER 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 17634413 ↗
• MalfunctionMay 22, 2023Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE RETROGRADE DRILL´S BLADE ACTUATOR WIRE BROKE, AND A LOUD CLICK SOUND, RESULTING IN DIFFICULTY TO RETRACT THE CUTTING BLADE WHILE DRILLING THE FEMUR TUNNEL. ALL THE BROKEN PIECES WERE SUCCESSFULLY RETRIEVED FROM THE PATIENT BY ARTERY AND GRASPERS. NON-SIGNIFICANT DELAY WAS REPORTED, AND THE PROCEDURE WAS FINISHED WITH A SMITH AND NEPHEW BACK UP DEVICE USED IN THE ORIGINALLY DRILLED BONE HOLE. NO VOID WAS LEFT IN THE PATIENT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16973402 ↗
• MalfunctionMay 8, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE RETROGRADE DRILL WAS BROKEN, THE INNER SHAFT WAS DETACHED FROM THE OUTER SLEEVE WHILE DRILLING. A DELAY GREATER THAN 30 MINUTES WAS REPORTED. 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 16892173 ↗
• InjuryOct 11, 2022Break; Break

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT PROCEDURE, AN ACCUFEX TRUNAV RETROGRADE DRILL BRA GOT BROKEN. SURGERY RESUMED AFTER NON-SIGNIFICANT DELAY OF 10 MINUTES WITH A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15581207 ↗
• InjuryOct 11, 2022Break; Break

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT PROCEDURE WITH ACUFEX RETROGRADE DRILL, AT THE TIME OF DOING THE RETROGRADE PROCESS, THE BLADE BREAK INSIDE THE OPERATIVE AREA. THE BROKEN PIECES WERE RETRIEVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A 10 MINUTES SURGICAL DELAY USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED. THE PATIENT CURRENT STATUS IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15581169 ↗
• InjurySep 28, 2022Break; Break

  IT WAS REPORTED THAT DURING AN ACL PROCEDURE, WHEN PERFORMING THE FEMUR TUNNEL AND TRYING TO OPEN THE 9MM TRUNAV RETROGRADE DRILL, THE DOCTOR DID NOT REMOVE THE DRILL FROM THE BONE AND THUS, THE DRILL BROKE. IT WAS REMOVED WITH THE HELP OF THE INSTRUMENTAL. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING A S+N BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED. THE PATIENT'S HEALTH CONDITION IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15499216 ↗
• InjuryMay 26, 2022Break; Break

  IT WAS REPORTED THAT DURING A PROCEDURE, THE RETROGRADE DRILL BIT BROKE AT THE END WHEN MAKING THE RETROGRADE TUNNEL. THE DRILL BIT WAS BROKEN INTO 2 PIECES: ONE PIECE WAS EASILY REMOVED, THE OTHER WAS REMOVED WITH MORE DIFFICULTY, AN EXPLORATION WAS NECESSARY TO VERIFY THE ABSENCE OF DEBRIS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NON-SIGNIFICANT SURGICAL DELAY USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14519403 ↗
• MalfunctionSep 6, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING USE INSTRUMENTS INSIDE THE PATIENT, WHEN USING THE TRUNAV THE WIRE THAT EXTENDS DOWN TO FLIP THE WING KINKED AND SEPARATED FROM THE GREY LEVER. THEREFORE, THE WING WAS NO LONGER ABLE TO BE RETRACTED. THEY HAD TO REVERSE TAP TO REMOVE, REAM LARGER AND SUPPLEMENT WITH EXTENDOBUTTON. A LARGER REAMER WAS REQUIRED. THE PROCEDURE WAS COMPLETED WITH A S+N BACK-UP DEVICE AND A SIGNIFICANT DELAY WAS REPORTED. NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12431004 ↗
• InjuryJun 13, 2021Break; Mechanical Jam; Break; Mechanical Jam

  IT WAS REPORTED THAT, DURING PROCEDURE, THE BLADE ON THE RETROGRADE DRILL COULD NOT BE DEPLOYED AND THE WIRE WAS BROKEN. BONE HOLE WAS MADE ACCORDING TO STANDARD PROCEDURE AND ALL BROKEN PIECES WERE RETRIEVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A BACKUP DEVICE AND NO SIGNIFICANT DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11988995 ↗
• MalfunctionJun 1, 2021Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THERE WAS NO LASER MARK ENGRAVED ON THE DEDICATED GUIDE WIRE OF THE RETROGRADE, THE DEVICE COULD NOT BE MEASURED DEPTH AND USED PROPERLY. THE PROCEDURE WAS COMPLETED WITH A S+N BACK-UP DEVICE. NO SIGNIFICANT DELAY WAS REPORTED, AND NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11917398 ↗
• InjuryJan 25, 2021Break; Break

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY, THE RETROGRADE DRILL BROKE WHEN THE SURGEON TRIED TO DOWNSHIFT TO PIERCE THE TUNNEL IN THE FEMUR. ALL PIECES WERE REMOVED. 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 11221310 ↗
• InjuryJan 24, 2021Break; Break

  IT WAS REPORTED THAT DURING THE SURGERY THE RETROGRADE DRILL COULD NOT BE OPENED IN THE JOINT AND THE WIRE WAS BROKEN. ALL THE BROKEN PIECES WERE REMOVED FROM THE PATIENT. NO SIGNIFICANT DELAY OR OTHER COMPLICATIONS WERE REPORTED. THE SURGERY WAS COMPLETED USING A SMITH AND NEPHEW BACK-UP DEVICE. 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 11221252 ↗
• MalfunctionAug 9, 2020Break; Break

  IT WAS REPORTED THAT DURING AN ACL RECONSTRUCTION, WHEN USING THE TRUNAV RETROGRADE DRILL 9MM IN THE FEMORAL CORTEX, IT WAS FOUND THAT THE TIP WAS DETACHED. THE TIP OF THE DEVICE WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE. 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 Information

  MAUDE report 10383249 ↗
• InjuryJul 15, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY SURGERY WHILE DRILLING THE FEMORAL TUNNEL THE TRUNAV DETACHED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT A SIGNIFICANT DELAY USING A BACK-UP DEVICE. 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: Foreign Body In Patient

  MAUDE report 10280238 ↗
• InjuryJul 14, 2020Break; Mechanical Jam; Break; Mechanical Jam

  IT WAS REPORTED THAT DURING SURGERY, THE ACUFEX LOCKED. THE DEVICE HAD A BREAKAGE AND THE PIECES WERE SUCCESSFULLY REMOVED. NO DELAY AND THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. 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: Injury

  MAUDE report 10273044 ↗