ACUFEX 72204046Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00885554037753), received between Jul 12, 2020 and Jan 30, 2026 — classified as 10 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Break” (13 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 30, 2026Detachment of Device or Device Component; Material Deformation

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY, ALL PARTS OF THE RETROGRADE DRILL WERE DETACHED WHEN THE SURGEON DRILLED AT THE TIBIAL SIDE. THE PROCEDURE WAS RESUMED, WITH A NON-SIGNIFICANT DELAY, USING A SIMILAR SN BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24223620 ↗
• MalfunctionSep 24, 2024Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE USER WAS UNABLE TO RETRACT THE BLADE OF THE RETROGRADE DRILL AFTER RETROGRADE REAMING. 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 20293917 ↗
• MalfunctionMar 20, 2024Break; Difficult to Open or Close; Break; Difficult to Open or Close

  IT WAS REPORTED THAT DURING A RETROGRADE DRILLING ON THE TIBIA, THE SPRING IN THE SOCKET THAT OPENS THE BLADE GAVE WAY ON THE 10 MM DRILL, THE SURGEON WAS UNSURE IF THE BLADE WAS OPEN COMPLETELY. THE TRUNAV RETROGRADE DRILL BROKE. THE PROCEDURE WAS COMPLETED WITH A S+N BACK UP DEVICE. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18942979 ↗
• MalfunctionMar 7, 2024Unstable; Insufficient Device Problem Information; Unstable; Insufficient Device Problem Information

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY, THE RETROGRADE DRILL WAS INTRODUCED TO MAKE THE TUNNEL, IT WAS EVIDENT THAT THE MOTOR WAS ROTATING, BUT THE TIP OF THE DRILL BIT DID NOT; BOTH CORTICES WERE CROSSED AND WHEN DOING THE RETROGRADE PART, THE BLADE CAME OUT AND THE IMPLANT MADE A SOUND. THE BLADE WAS REMOVED TO CHECK AND IT WAS EVIDENT THAT THE BLADE CAME LOOSE. SURGERY WAS COMPLETED WITH A BACK-UP DEVICE INSTEAD. THERE WAS A DELAY GREATER THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED. PATIENT'S STATUS IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18858356 ↗
• InjuryDec 16, 2022Break; Break

  IT WAS REPORTED THAT DURING A KNEE PROCEDURE, THE REMOVABLE END OF THE RETROGRADE DRILL BROKE OFF IN THE KNEE. THE BROKEN PIECE WAS REMOVED BUT IT IS UNKNOWN HOW. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A BACK-UP DEVICE, IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY DUE TO THE REPORTED EVENT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15996379 ↗
• InjuryDec 13, 2022Break; Break

  IT WAS REPORTED THAT DURING AN ACL (BTB) RECONSTRUCTION PROCEDURE, THE WIRE OF THE BLADE FROM THE RETROGRADE DRILL BROKE AFTER THE BONE HOLE WAS MADE USING THE DEVICE, UPON DRILL REMOVAL. ALL BROKEN PARTS WERE REMOVED FROM THE PATIENT; HOWEVER, IT IS UNKNOWN HOW THEY WERE RETRIEVED. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15973042 ↗
• InjuryJul 20, 2022Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY PROCEDURE, THE TIP OF THE 10MM TRUNAV RETROGRADE DRILL BROKE OFF WHILE ANTEGRADE REAMING. THE BROKEN PIECE WAS WHOLLY REMOVED BY USING A SMALL OSTEOTOME TO CREATE A SPACE NEXT TO THE PIECE, AND USING A SMALL NEEDLE HOLDER ONE SIDE OF THE JAW WAS PLACED IN THE CANNULATION OF THE DRILL, WHILE THE OTHER WAS PLACED OUTSIDE THE DRILL IN THE SPACE CREATED WITH THE OSTEOTOME, AND IT WAS PULLED OUT AT THAT POINT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A BACK-UP DEVICE IN THE SAME ORIGINALLY DRILLED BONE HOLE. A SURGICAL DELAY GREATER THAN 30MIN TOOK PLACE, AND NO FURTHER COMPLICATIONS WERE REPORTED. THE PATIENT CURRENT STATUS IS NORMAL POST OP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15066074 ↗
• InjuryNov 25, 2021Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY PROCEDURE, THE RETROGRADE DRILL DEVICE BROKE WHEN THE DOCTOR INSERTED INTO THE PATIENT, PIECES WERE REMOVED WITH THE AID OF A GUIDE WIRE. 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 12875453 ↗
• InjuryAug 17, 2021Break; Break

  IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY, WHEN DRILLING THE FEMUR WITH THE ACUFEX TRUNAV RETROGRADE DRILL, THE DRILL TIP BROKE OFF INSIDE THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE. THE PIECE WAS SUCCESSFULLY REMOVED FROM THE PATIENT USING A GRASPER. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12334107 ↗
• InjuryAug 10, 2021Break; Break

  IT WAS REPORTED THAT DURING AN ACL RECONSTRUCTION CASE, THE TRUNAV RETROGRADE DRILL WAS BROKEN WHEN THE INSTRUMENT WAS BEING USED INTERNAL TO THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A 9.5MM TRUNAV RETROGRADE DRILL. THERE WAS NOT A SIGNIFICANT DELAY. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12300279 ↗
• MalfunctionJun 10, 2021Break; Break

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY, THE TRUNAV RETROGRADE DRILL'S WIRE AT THE END OF THE DRILL WAS BROKEN. THE PROCEDURE WAS COMPLETED WITH DELAY GREATER THAN 30 MINUTES USING A BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11974160 ↗
• MalfunctionJun 9, 2021Break; Break

  IT WAS REPORTED THAT DURING AN ACL PROCEDURE, THE RETROGRADE DRILL BROKE. THERE WAS NO DELAY AND A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE SURGERY. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11965781 ↗
• InjuryMay 6, 2021Break; Break

  IT WAS REPORTED THAT, DURING THE PROCEDURE, THE "10MM TRUNAV RETROGRADE DRILL BIT" BROKE INTO 2 PIECES. IT IS UNKNOWN IF A BACKUP DEVICE WAS AVAILABLE OR IF THERE WAS A DELAY IN THE SURGICAL PROCEDURE. NO FURTHER 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 11786794 ↗
• InjuryMar 4, 2021Break; Break

  IT WAS REPORTED THAT, DURING A KNEE PROCEDURE AND WHEN ATTEMPTING TO FLIP THE TRUNAV DRILL, THE SMALL ROD THAT OPENS THE REAMER BROKE AND IT WAS IMPOSSIBLE TO RETROGRADE REAM. THE PROCEDURE WAS COMPLETED WITH A BACKUP DEVICE AND NO SIGNIFICANT DELAY OR FURTHER COMPLICATIONS 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 11416213 ↗
• InjurySep 25, 2020Break; Break

  IT WAS REPORTED THAT DURING ACL RECONSTRUCTION, THE ACUFEX TRUNAV RETROGRADE DRILL, FAILED WHEN ATTEMPTING TO DRILL THROUGH THE LATERAL FEMORAL CORTEX, SPLITING IN TWO PIECES, ALL PIECES WERE REMOVED USING PICKUPS AND HEMOSTAT; THE PROCEDURE WAS COMPLETED USING A COMPETITOR DEVICE, NO OTHER COMPLICATIONS OR DELAY 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; No Information

  MAUDE report 10585948 ↗
• InjuryJul 12, 2020Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT DURING AN ALL INSIDE ACL, IT WAS FOUND THAT THE 2.4MM DRILL WIRE INCLUDED IN THE TRUNAV SET WAS DEFECTIVE. THE LASER MARKING AT THE TIP OF THE DRILL WAS MISSING. WHEN POSITIONED THE DRILL APPROXIMATELY AS IT SHOULD HAVE BEEN WITH LASER MARKING AND WHEN THE ACUFEX WAS MOVED IN THE GAUGE OVER THE WIRE FROM THE OUTSIDE, THE GAUGE SHOWED A FEMORAL TUNNEL LENGTH OF 65MM, WHICH WAS CONSIDERED VERY UNLIKELY AND IT WAS NECESSARY TO USED ALTERNATIVE MEASUREMENT METHODS. THE PROCEDURE WAS COMPLETED WITHOUT 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: No Known Impact Or Consequence To Patient

  MAUDE report 10262177 ↗