ACUFEX 72204042Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00885554037715), received between Sep 17, 2020 and Feb 24, 2026 — classified as 5 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Break” (15 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 24, 2026Break

  IT WAS REPORTED THAT DURING A ACL PROCEDURE, THE TIP OF THE 8MM RETROGRADE DRILL BROKE. THE BROKEN PIECES WERE REMOVED FROM INSIDE THE PATIENT USING A GRASPER. 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 24431228 ↗
• MalfunctionNov 5, 2025Break; Break

  IT WAS REPORTED THAT, DURING AN ACL RECONSTRUCTION, DURING THE DRILLING PROCESS OF THE FEMORAL TUNNEL, THE RETROGRADE DRILL WAS NOT WORKING PROPERLY, AND THE 8MM DRILL WING COULD NOT BE OPENED ((B)(4)). AFTERWARDS, A SECOND RETROGRADE DRILL BROKE ON THE HEAD PART; THE BROKEN PART WAS RETRIEVED WITH A GRASPER ((B)(4)). THE PROCEDURE WAS RESUMED, WITH A DELAY OF LESS THAN 30 MINUTES, USING A SIMILAR SN BACK-UP, A 7.5MM DRILL. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23477968 ↗
• MalfunctionMar 25, 2025Break; Difficult to Open or Close; Break; Difficult to Open or Close

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY PROCEDURE, THE RETROGRADE DRILL 8 MM WAS PHYSICALLY BROKEN AND COULD NOT BE OPENED BY PUSHING THE GREY SLEEVE WHEN THE SURGEON WANTED TO DRILL RETROGRADELY FROM THE TIBIAL TUNNEL ENTRY. SURGERY WAS COMPLETED WITH A SMITH AND NEPHEW 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 21687310 ↗
• MalfunctionMar 6, 2025Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE RETROGRADE DRILL WAS UNABLE TO OPEN OR DEPLOY THE BLADE AFTER DRILLING DUE TO A BROKEN CONNECTOR BETWEEN THE BLADE AND THE ACTIVATION GREY KNOB. 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 21533562 ↗
• MalfunctionFeb 25, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ACL PROCEDURE, THE 8MM RETROGRADE DRILL WAS USED, BUT WHEN PUTTING THE DEVICE AWAY, IT GOT STUCK AND BROKE. THE BROKEN DRILL WAS REMOVED, AND THE SURGERY WAS COMPLETED SUCCESSFULLY. THE PROCEDURE WAS COMPLETED WITHOUT SURGICAL DELAY USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21462225 ↗
• MalfunctionFeb 18, 2025Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT DURING SET UP, WHEN THE CUSTOMER OPENED THE RETROGRADE DRILL PACKAGE, IT WAS ALREADY OPENED AND THE ADHESIVE WAS MISSING. A BACKUP DEVICE WAS AVAILABLE, AND NO SURGICAL DELAY WAS REPORTED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21402052 ↗
• InjuryMay 10, 2024Failure to Cycle; Failure to Cycle

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE RETROGRADE DRILL BLADE TIP COULD NOT BE RETURNED AFTER DRILLING THE BONE HOLE. THE BONE HOLE WAS MADE INTO A THROUGH HOLE. THE PROCEDURE WAS COMPLETED USING THE SAME REPORTED DEVICE. THERE WAS A 10-MINUTE DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Perforation

  MAUDE report 19291584 ↗
• MalfunctionOct 16, 2023Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE RETROGRADE DRILL BIT BROKE WHEN ATTEMPTING TO FLIP IT, THE DRILL BIT WAS STILL ATTACHED AND WAS PULLED OUT FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITHOUT SURGICAL DELAY USING A S+N BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17940762 ↗
• MalfunctionJul 12, 2023Break; Break

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE DOCTOR WENT TO USE THE RETROGRADE DRILL, BEFORE HE ACTIVATED THE DRILL TO MAKE THE TUNNEL OF THE FEMUR, IT BROKE AND THE PIECE 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 17307849 ↗
• MalfunctionFeb 27, 2023Break; Break

  IT WAS REPORTED THAT DURING AN KNEE ARTHROSCOPY, THE RETROGRADE DID NOT WORK PROPERLY, IT BROKE INTO PIECES. THE DEVICE DID NOT BREAK INSIDE THE PATIENT. 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 16443683 ↗
• MalfunctionJun 3, 2022Break; Break

  IT WAS REPORTED THAT DURING AN ACL PROCEDURE, WHEN STARTING THE PREPARATION OF THE FEMORAL TUNNEL, THE SURGEON IDENTIFIED THAT THE TRUNAV RETROGRADE DRILL WAS NOT PROGRESSING, THEN, UPON MANUALLY ROTATING THE DEVICE, THE DRILL DID NOT MOVE, SO HE REMOVED IT AND SAW THAT THE DRILL HAD BROKEN OUTSIDE. THE PROCEDURE WAS COMPLETED WITHOUT SURGICAL DELAY USING A S+N BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14596878 ↗
• InjuryMay 17, 2022Break; Break

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE FIN OF THE RETROGRADE DRILL BROKE DURING DEPLOYMENT. THE BOTTOM HOOK WAS NOT ATTACHED TO THE REST. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED OR IF THERE WAS A DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14421387 ↗
• MalfunctionAug 13, 2021Break; Break

  IT WAS REPORTED THAT DURING USE INSTRUMENTS INSIDE THE PATIENT IN AN ARTHROSCOPY, BEFORE MILLING THE RETROGRADE WAS IDENTIFIED THAT THE TOOTH WAS ALREADY BROKEN, IT WAS NOT POSSIBLE TO MILL THE BONE. THE PROCEDURE WAS COMPLETED WITH A S+N BACK-UP DEVICE. NO DELAY WAS REPORTED, AND NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12320611 ↗
• MalfunctionJun 24, 2021Break; Break

  IT WAS REPORTED THAT, DURING AN ACL PROCEDURE, WHEN THE RETROGRADE DRILL WAS DRILLING, IT BROKE OFF AND A COMPONENT WAS DISASSEMBLED. THE DEVICE BROKE BEFORE BEING INSERTED COMPLETELY IN THE PATIENT, NOTHING WAS LEFT INSIDE THE PATIENT. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE. NO SIGNIFICANT DELAY AND NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12060160 ↗
• MalfunctionJun 18, 2021Crack; Crack

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPIC PROCEDURE, WHEN THE "8.0MM ACUFEX TRUNAV RETROGRADE DRILL" WAS ACTIVATED TO OPEN THE BLADE, IT WAS FOUND THAT THE MATERIAL WAS ALREADY BROKEN AND THE CUTTER BLADE COULD NOT BE OPENED. THERE WAS NO BREAK INSIDE THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12026302 ↗
• InjuryDec 13, 2020Break; Break

  IT WAS REPORTED THAT, DURING AN UNSPECIFIED SURGERY, THE CUTTER BLADE OF THE "8MM ACUFEX TRUNAV RETROGRADE DRILL" COULD NOT BE DEPLOYED AND OPENED IN THE JOINT BECAUSE THE WIRE THAT RETRACTS THE CUTTER BLADE BROKE. THE BROKEN WIRE WAS SUCCESSFULLY REMOVED FROM THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SIGNIFICANT DELAY USING A BACK-UP DEVICE. 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 10999182 ↗
• MalfunctionOct 8, 2020Break; Break

  IT WAS REPORTED THAT DURING DRILLING, THE LAST PART OF THE ACUFEX TRUNAV WAS BROKEN. THE MALFUNCTION WAS SOLVED WITH NO DELAYS OR PATIENT HARM USING THE SAME DEVICE. NO PIECES FELT INTO THE PATIENTS WOUND. 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 10648795 ↗
• InjuryOct 6, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT DURING ACL RECONSTRUCTION PROCEDURE, WHEN THE BLADE WAS OPENED AND MADE A SOCKET, THE SHAFT WAS ROTATING, BUT THE BLADE WAS NOT ROTATING. WHEN THE SHAFT PART WAS RECOVERED FROM THE OUTSIDE OF THE FEMUR, A BROKEN BLADE AND A GUIDE WIRE REMAINED IN THE BONE HOLE. ALL BROKEN PIECES WERE REMOVED FROM THE PATIENT. 20 MINUTES DELAY AND A BACK UP WAS AVAILABLE TO COMPLETE THE PROCEDURE. 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 10639670 ↗
• InjurySep 17, 2020Break; Break

  IT WAS REPORTED THAT DURING THE SURGERY, THE TIP OF THE DRILL BROKE OFF WHEN THE SURGEON ATTEMPTED TO RETRACT THE CUTTING BLADE LEAVING THE TIP CONNECTED ONLY BY THE ACTUATION MECHANISM. THE TIP HAD TO BE BROKEN FROM THE DRILL IN TO ORDER TO BE REMOVED WITH A GRASPER. NO SIGNIFICANT DELAY WAS REPORTED. NO BACK-UP DEVICE REQUIRED AS THE DRILLING WAS COMPLETE. 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 10546003 ↗