LEVEL ONE 25-473-70-07Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00888118041548), received between Feb 1, 2018 and Feb 12, 2019 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 12, 2019Temperature Problem; Device Handling Problem; Temperature Problem; Device Handling Problem

  IT WAS REPORTED THAT THE PATIENT RECEIVED HEAT BURNS ON THEIR CHEEK. THE TWIST DRILL WAS BEING USED AT 30,000 RPM WITH A TROCAR. IT IS STATED IN IFU 90-274-92-40 AND 91-600-00-41 UNDER PRECAUTIONS "WHEN USING TWIST DRILLS, COPIOUS AMOUNTS OF IRRIGATION ARE MANDATORY TO ALLEVIATE EXCESSIVE HEAT GENERATION, WHICH CAN LEAD TO BONE NECROSIS, AND IN EXTREME CASES, SOFT TISSUE BURNS THROUGH CONTACT WITH TROCAR AND CANNULA." AND "TWIST DRILLS ARE NOT DESIGNED TO BE USED AT SPEEDS IN EXCESS OF 5000 RPM."

  Patient problems: Burn(s)

  MAUDE report 8332125 ↗
• InjuryJun 8, 2018Break; Break

  IT WAS REPORTED THAT TWO TWIST DRILLS BROKE. ALL PIECES WERE REMOVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7584209 ↗
• InjuryFeb 15, 2018Temperature Problem; Device Handling Problem; Temperature Problem; Device Handling Problem

  IT WAS REPORTED THAT THE PATIENT RECEIVED HEAT BURNS BILATERALLY ON THEIR CHEEKS. THE TWIST DRILL WAS BEING USED AT 35,000 RPM WITH A TROCAR. IT IS STATED IN IFU 90-274-92-40 AND 91-600-00-41 UNDER PRECAUTIONS "WHEN USING TWIST DRILLS, COPIOUS AMOUNTS OF IRRIGATION ARE MANDATORY TO ALLEVIATE EXCESSIVE HEAT GENERATION, WHICH CAN LEAD TO BONE NECROSIS, AND IN EXTREME CASES, SOFT TISSUE BURNS THROUGH CONTACT WITH TROCAR AND CANNULA." AND "TWIST DRILLS ARE NOT DESIGNED TO BE USED AT SPEEDS IN EXCESS OF 5000 RPM." THE BURNT TISSUE WAS CUT OUT LIKE A SCAR REVISION.

  Patient problems: Burn(s)

  MAUDE report 7272819 ↗
• MalfunctionFeb 1, 2018Break; Human-Device Interface Problem; Break; Human-Device Interface Problem

  THE END OF THE TWIST DRILL BROKE OFF AND STUCK INTO THE SLEEVE OF THE SCRUB TECH'S GOWN. THE SKIN WAS NOT PUNCTURDED AND MEDICAL CARE WAS NOT NEEDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7234824 ↗