NA 60-10512Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04546540366481), received between Nov 22, 2019 and Nov 22, 2019 — 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.

• MalfunctionNov 22, 2019Fracture; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A CRANIOTOMY, WHILE THE SURGEON WAS DRILLING DOWN INTO SKULL, THE TWIST DRILL'S TIP FRACTURED OFF IN SKULL. THE FRACTURED PORTION WAS LEFT IN THE BONE AND THE REST OF PRODUCT WAS DISCARDED BY SURGICAL STAFF. THE PROCEDURE WAS COMPLETED SUCCESSFULLY OTHERWISE.

  Patient problems: Foreign Body In Patient

  MAUDE report 9365471 ↗