Medicon 68.76.84Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04046826312350), received between May 4, 2019 and May 4, 2019 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Fracture” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 4, 2019Fracture; Fracture

  IN ACCORDANCE WITH THE SURGEON'S REPORT, DURING PLASTIC SURGERY HE ATTEMPTED TO USE A TWIST DRILL, BUT THE DEVICE BROKE IMMEDIATELY. IT WAS REPLACED BY AN IDENTICAL DRILL BIT FROM THE SAME LOT, WHICH ALSO BROKE IMMEDIATELY. THE FRACTURED TIP OF THE SECOND DRILL WAS DEFLECTED BY THE BONE AND FLEW AT THE SURGEON'S FACE, BARELY MISSING HIS EYE. NO PATIENT HARM. THIS REPORT IS FOR DEVICE #2 OF 2 USED DURING THE SAME PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8580699 ↗
• MalfunctionMay 4, 2019Fracture; Fracture

  IN ACCORDANCE WITH THE SURGEON'S REPORT, DURING PLASTIC SURGERY HE ATTEMPTED TO USE A TWIST DRILL, BUT THE DEVICE BROKE IMMEDIATELY. IT WAS REPLACED BY AN IDENTICAL DRILL BIT FROM THE SAME LOT, WHICH ALSO BROKE IMMEDIATELY. THE FRACTURED TIP OF THE SECOND DRILL WAS DEFLECTED BY THE BONE AND FLEW AT THE SURGEON'S FACE, BARELY MISSING HIS EYE. NO PATIENT HARM. THIS REPORT IS FOR DEVICE #1 OF 2 USED DURING THE SAME PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8580688 ↗