NA 91-15920Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04546540493712), received between Aug 30, 2018 and Dec 19, 2018 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

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 16, 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.

• MalfunctionDec 19, 2018Break; Difficult to Remove

  IT WAS REPORTED THAT TWO DRILLS BROKE; ONE PIECE COULD NOT BE RETRIEVED AND REMAINED IN-SITU IN THE PATIENT, AND THE OTHER PIECE WAS RETRIEVED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8181092 ↗
• InjuryAug 30, 2018Component Missing

  IT WAS REPORTED THAT DURING SURGERY THE LONG DRILL BIT WAS FOUND TO HAVE THE TIP MISSING. AN X-RAY WAS ORDERED WHICH IDENTIFIED THE DRILL TIP WITHIN THE BONE. AT THIS TIME THERE IS NO MEDICAL INTERVENTION NOR ADVERSE CONSEQUENCE TO REPORT.

  Patient problems: Foreign Body In Patient

  MAUDE report 7832906 ↗