NA 1806-5020SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04546540197016), received between Feb 6, 2023 and Feb 6, 2023 — classified as 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. How this data works · Data updated Oct 13, 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.

• MalfunctionFeb 6, 2023Break; Fracture; Break; Fracture

  IT WAS REPORTED BY THE CUSTOMER THAT "A PIECE OF DRILL BROKE OFF IN PATIENT, TO BE LEFT IN AS PER SURGEON". IT WAS REPORTED THAT THE DRILL BIT PIECE REMAINS IN PATIENT AS IT WAS DETERMINED IT COULD CAUSE DAMAGE IF ATTEMPTS WERE MADE TO REMOVE.

  Patient problems: Foreign Body In Patient

  MAUDE report 16308661 ↗