ACUFEX 72204048Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00885554037777), received between Jul 27, 2021 and Jan 23, 2024 — classified as 3 injuries, 2 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 23, 2024Break; Break

  IT WAS REPORTED THAT DURING A MENISCUS TRANSPLANTATION, THE PROCEDURE STARTED WITH THE 2.4MM GUIDE TO MAKE THE FIRST TIBIAL TUNNEL, THE INITIATOR WAS LEFT FIXED IN THE TUNNEL, THE DRILL WAS REMOVED TO PLACE THE RETROGRADE DRILL BIT, THE SECOND DRILLING WAS MADE, THE FIRST INITIATOR BIT OF THE DRILL WAS REMOVED UNTIL IT STOPPED AND PROCEEDED TO DEPLOY THE BLADE, BUT IT DID NOT DEPLOY BECAUSE IT WAS FOUND LOOSE IN THE BUTTON PART OF THE RETROGRADE DRILL. THE BROKEN PIECE WAS REMOVED FROM PATIENT. THE PROCEDURE WAS COMPLETED WITH A DELAY OF 5 MINUTES USING A SMITH AND NEPHEW BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18563253 ↗
• InjuryDec 9, 2022Break; Break

  IT WAS REPORTED THAT, DURING AN UNSPECIFIED PROCEDURE, THE RETROGRADE DRILL BROKE IN 3 PLACES INSIDE THE TUNNEL. NON-SIGNIFICANT DELAY WAS REPORTED, AND 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 15954825 ↗
• InjuryDec 5, 2022Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY WHEN DRILLING THE BONE, THE DOCTOR REMOVED THE DRILL BEFORE ACTIVATING THE RETROGRADE NUMBERING, AND THE DRILL WITHOUT THE TIP WAS NOTICED. X-RAY WAS DONE AND THE DRILL WAS INSIDE THE BONE. IT IS UNKNOWN IF THERE WAS AN EXCESS FORCE, BUT THE MATERIAL BROKE RIGHT AT THE TIP. THE SAME WAS REMOVED FROM THE PATIENT, USING THE SCREW/SCREW TECHNIQUE. THE PROCEDURE WAS COMPLETED WITH A SIGNIFICANT DELAY USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15921656 ↗
• MalfunctionJul 4, 2022Break; Break

  IT WAS REPORTED THAT THE END OF THE RETROGRADE DRILL WAS BROKEN. IT IS UNKNOWN WHEN THE EVENT HAPPENED RELATIVE TO SURGERY. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE. THERE WAS NO SURGICAL DELAY, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14911685 ↗
• InjuryJul 27, 2021Break; Break

  IT WAS REPORTED THAT DURING USE IN AN ARTHROSCOPY, THE RETROGRADE DRILL BROKE. ALL THE BROKEN PIECES WERE REMOVED FROM THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING THE SAME DEVICE. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12235006 ↗