NA 60-16050Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04546540356529), received between Dec 10, 2018 and Dec 10, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 10, 2018Fracture; Detachment of Device or Device Component; Device Fell

  IT WAS REPORTED THAT THE TWIST DRILL TIP FRACTURED OFF DURING A CASE AND FALL INTO PATIENT. THE PROCEDURE WAS DELAYED OVER 45-60 MINUTES FOR THE X-RAY TO RECOVER AND REMOVE IT FROM THE PATIENT.

  Patient problems: No Code Available

  MAUDE report 8147932 ↗