ACUFEX 7208686Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03596010427373), received between Jul 27, 2022 and Jul 10, 2023 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 10, 2023Break; Break

  IT WAS REPORTED THAT DURING AN ACL PROCEDURE, A 5.0MM DRILL BROKE WHILE MILLING THE TUNNEL. SURGERY CONTINUED WITHOUT ANY DELAY WITH THE BACK-UP DRILL. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17290371 ↗
• MalfunctionSep 11, 2022Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY PROCEDURE, A 5.0MM CANNULATED DRILL BIT (B)(4) AND A 4.5MM CANNULATED DRILL BIT (B)(4) WERE BROKEN. 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 15397980 ↗
• InjuryJul 27, 2022Break; Break

  IT WAS REPORTED THAT, DURING THE ARTHROSCOPY THE DYONICS DRILL DEVICE BROKE INSIDE THE PATIENT'S JOINT. IT WAS REMOVED WITH THE GRASPER FORCEPS "TWEEZERS" IMMEDIATELY. THE PROBLEM WAS NOTICED DURING USE, NO DELAY OR FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15114636 ↗