ACUFEX 72204041Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00885554037708), received between Jan 14, 2021 and Dec 5, 2023 — classified as 3 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 5, 2023Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT WHEN THE RETROGRADE DRILL 7.5 MM WAS OPENED, IT WAS NOTICED THAT THE WIRES WERE NOT PACKAGED INSIDE THE BOX, THE WIRES WERE COMING OUT OF THE STERILE PACKAGING. NO CASE WAS REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18267455 ↗
• MalfunctionNov 29, 2023Break; Break

  IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY, THE BLADE BROKE THE TIP OF THE ACUFEX RETROGRADE DRILL. THE PROCEDURE WAS COMPLETED WITH A SMITH AND NEPHEW BACK UP DEVICE. THERE WAS A DELAY GREATER THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18229677 ↗
• InjuryOct 5, 2022Break; Failure to Fire; Break; Failure to Fire

  IT WAS REPORTED THAT DURING AN ACL RECONSTRUCTION PROCEDURE, THE TIP OF BLADE IN THE 7.5MM RETROGRADE DRILL COULD NOT DEPLOYED AND THE WIRE THAT RETRACTS THE CUTTER BLADE WAS BROKEN WHEN THE 4.9MM BONE HOLE WAS MADE; AFTER RETROGRADE DRILLING/BEFORE CUTTER RETRACTION THE BROKEN PIECES REMOVED FROM PATIENT. 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 15545352 ↗
• MalfunctionMar 26, 2022Break; Break

  IT WAS REPORTED THAT DURING USE IN A KNEE ARTHROSCOPY, THE SURGEON STARTED TO DRILL AND THE RETROGRADE DRILL SPLIT ON THE ATTACHMENT POINT. THE PROCEDURE WAS COMPLETED WITH NON-SIGNIFICANT SURGICAL DELAY 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 13923366 ↗
• InjuryMar 23, 2021Break; Break

  IT WAS REPORTED THAT DURING AN ACL RECONSTRUCTION, AS THE ACUFEX TRUNAV RETROGRADE DRILL, 7.5MM WAS BEING USED TO REAM OVER THE 2.4 MM GUIDE WIRE, THE TIP OF THE DRILL BROKE OFF AND GOT STUCK IN THE FEMORAL TUNNEL. THE BROKEN PART WAS RETRIEVED FROM THE PATIENT. THE PROCEDURE WAS FINISHED WITH A BACKUP DEVICE AND A DELAY OF 10 MINUTES. NO PATIENT 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 11555715 ↗
• InjuryJan 14, 2021Break; Break

  IT WAS REPORTED THAT DURING AN ACL RECONSTRUCTION PROCEDURE, INTERNAL TO THE PATIENT, THE RETROGRADE DRILL BROKE WHEN DRILLING A BONE HOLE. ALL BROKEN PIECES WERE REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A SIGNIFICANT DELAY USING A BACK-UP DEVICE. NO PATIENT INJURY OR 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 11170236 ↗