NA 60-15995Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07613327090017), received between Aug 27, 2019 and Aug 29, 2019 — classified as 2 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 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.

• InjuryAug 29, 2019Break

  IT WAS REPORTED BY A SURGEON THAT A DRILL BIT BROKE AT THE TIP DURING A SURGICAL PROCEDURE. THE BROKEN PORTION OF THE DRILL WAS NOT REMOVED FROM THE PATIENT BODY. OTHERWISE, THE PROCEDURE WAS REPORTED AS COMPLETED SUCCESSFULLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8947236 ↗
• MalfunctionAug 29, 2019Break

  IT WAS REPORTED BY A SURGEON THAT A DRILL BIT BROKE AT THE TIP DURING A SURGICAL PROCEDURE. THE BROKEN PORTION OF THE DRILL WAS REMOVED FROM THE PATIENT BODY. THE COMPLAINANT WAS NOT AWARE OF MEDICAL INTERVENTION OR ADVERSE CONSEQUENCES WITH THIS EVENT, BUT THE PROCEDURE WAS REPORTED AS COMPLETED SUCCESSFULLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8945699 ↗
• InjuryAug 27, 2019Break

  IT WAS REPORTED BY A SURGEON THAT A DRILL BIT BROKE AT THE TIP DURING A SURGICAL PROCEDURE. THE BROKEN PORTION OF THE DRILL REMAINS IN THE PATIENT'S JAW BONE. THERE WAS MEDICAL INTERVENTION, BUT THE PROCEDURE WAS REPORTED AS COMPLETED SUCCESSFULLY.

  Patient problems: Foreign Body In Patient

  MAUDE report 8936876 ↗
• MalfunctionAug 27, 2019Break

  IT WAS REPORTED BY A SURGEON THAT A DRILL BIT BROKE AT THE TIP DURING A SURGICAL PROCEDURE. THE BROKEN PORTION OF THE DRILL WAS REMOVED FROM THE PATIENT BODY. THE COMPLAINANT WAS NOT AWARE OF MEDICAL INTERVENTION OR ADVERSE CONSEQUENCES WITH THIS EVENT, BUT THE PROCEDURE WAS REPORTED AS COMPLETED SUCCESSFULLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8936851 ↗
• MalfunctionAug 27, 2019Break; Detachment of Device or Device Component

  IT WAS REPORTED BY A SURGEON THAT A DRILL BIT BROKE AT THE TIP DURING A SURGICAL PROCEDURE. THE BROKEN PORTION OF THE DRILL WAS REMOVED FROM THE PATIENT BODY. THE COMPLAINANT WAS NOT AWARE OF MEDICAL INTERVENTION OR ADVERSE CONSEQUENCES WITH THIS EVENT, BUT THE PROCEDURE WAS REPORTED AS COMPLETED SUCCESSFULLY.

  Patient problems: Foreign Body In Patient

  MAUDE report 8935596 ↗