ACUFEX 72204047Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00885554037760), received between Oct 1, 2020 and Mar 28, 2025 — classified as 5 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 28, 2025Break; Break

  IT WAS REPORTED THAT DURING A TIBIAL ACL PROCEDURE, THE ACUFEX TRUNAV RETROGRADE DRL 10.5 MM BROKE WHEN DRILLING ON THE TIBIA OVER TOP OF THE PIN, AS THE OUTER CORTEX ON THE TIBIA WAS HARD AND WAS HAVING A TOUGH TIME BREAKING THROUGH. THE METAL END THAT IS CHUCKED UP, SEPARATED FROM THE ORANGE ATTACHMENT PIECE ON THE DRILL ITSELF. THE PROCEDURE WAS COMPLETED WITH A SMITH AND NEPHEW BACK UP DEVICE. THERE WAS A DELAY LESS THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21725572 ↗
• MalfunctionMay 22, 2023Break; Break

  IT WAS REPORTED THAT DURING A PROCEDURE, THE TIP OF THE RETROGRADE DRL 10.5MM WAS BROKEN. THE PROCEDURE WAS COMPLETED WITH A NON-SIGNIFICANT SURGICAL DELAY USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16976379 ↗
• MalfunctionAug 18, 2022Break; Break

  IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY PROCEDURE, A TOTAL OF TWO (2) 10.5MM TRUNAV RETROGRADE DRILL DEVICES EASILY BROKE WHEN HANDLE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NON-SIGNIFICANT DELAY USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15254299 ↗
• InjuryMay 6, 2021Firing Problem; Firing Problem

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY PROCEDURE, THE TRUNAV DRILL WAS DRILLED OVER THE GUIDE PIN, ONCE THE DISTAL DRILL TIP ENTERED THE JOINT AND THE BLADE WAS READY FOR DEPLOYMENT THE BLADE WOULD NOT DEPLOY USING THE STANDARD TECHNIQUE. THE DRILL MECHANISM WOULD NOT ALLOW THE BLADE TO FLIP ONCE INSIDE THE JOINT. THE PROCEDURE WAS COMPLETED WITH A BACKUP DEVICE AND NO SIGNIFICANT DELAY OR PATIENT COMPLICATION WAS 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 11787700 ↗
• InjuryMay 6, 2021Firing Problem; Firing Problem

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY PROCEDURE, THE TRUNAV DRILL WAS DRILLED OVER THE GUIDE PIN, ONCE THE DISTAL DRILL TIP ENTERED THE JOINT AND THE BLADE WAS READY FOR DEPLOYMENT THE BLADE WOULD NOT DEPLOY USING THE STANDARD TECHNIQUE. THE DRILL MECHANISM WOULD NOT ALLOW THE BLADE TO FLIP ONCE INSIDE THE JOINT. THE PROCEDURE WAS COMPLETED WITH A BACKUP DEVICE AND NO SIGNIFICANT DELAY OR PATIENT COMPLICATION WAS 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 11787681 ↗
• InjuryMay 6, 2021Break; Break

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY PROCEDURE, THE TRUNAV DRILL WAS DRILLED OVER THE GUIDE PIN, ONCE THE DISTAL DRILL TIP ENTERED THE JOINT AND THE BLADE WAS READY FOR DEPLOYMENT THE BLADE WOULD NOT DEPLOY USING THE STANDARD TECHNIQUE. THE DRILL MECHANISM ON THE DRILL BROKE OFF DURING THE DRILLING PROCESS. THE PROCEDURE WAS COMPLETED WITH A BACKUP DEVICE AND NO SIGNIFICANT DELAY OR PATIENT COMPLICATION WAS 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 11787667 ↗
• InjuryDec 19, 2020Break; Break

  IT WAS REPORTED THAT, DURING A PCL PROCEDURE, WHEN THE "10.5MM TRUNAV RETROGRADE DRILL" WAS DRILLING THE THE TIBIA TUNNEL TOWARDS THE JOINT SPACE, IT WAS NOTICED THAT THE TOP PORTION OF THE DRILL BROKE OFF. THE LOOSE PIECE WAS COMPLETELY REMOVED FROM THE PATIENT WITH AN ARTERY DEVICE AND NO OTHER LOOSE BODIES WERE LEFT BEHIND. 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 11043022 ↗
• InjuryOct 1, 2020Break; Break

  IT WAS REPORTED THAT DURING AN ACL,PCL PROCEDURE, WHILE USING A 10.5MM COMPETITOR FLIP CUTTER IT BROKE, THEREFORE, AN 10.5MM RETROGRADE DRILL WAS USED. WHILE USING THE DRILL IT WAS NOTICED THAT THE BLADE WAS NOT FULLY SEEN AND THAT THE WIRE OF THE DEVICE WAS BROKEN WHICH CAUSED THAT THE BLADE WAS UNABLE TO BE DEPLOYED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SIGNIFICANT DELAY USING COMPETITOR 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 Clinical Signs, Symptoms or Conditions; No Information

  MAUDE report 10611136 ↗