NA 1806-4255SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04546540196750), received between Jun 11, 2021 and Jul 12, 2021 — classified as 2 malfunctions.

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. 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.

• MalfunctionJul 12, 2021Break; Break

  DURING SURGERY, THE DRILL BIT BROKE IN CONTACT WITH THE NAIL INSIDE THE PATIENT'S BONE. THE TIP OF THE DRILL BIT HAS REMAINED IN THE PATIENT BONE. THE SURGEON WAS TRYING TO DRILL THROUGH THE PATIENT'S BONES, EVEN THOUGH IT WAS SO HARD.

  Patient problems: Foreign Body In Patient

  MAUDE report 12149291 ↗
• MalfunctionJun 11, 2021Break; Break

  AS REPORTED: DURING SURGERY, THE DRILL BIT BROKE IN CONTACT WITH THE NAIL INSIDE THE PATIENT'S BONE. THE TIP OF THE DRILL BIT HAS REMAINED IN THE PATIENT BONE. THE SURGEON WAS TRYING TO DRILL THROUGH THE PATIENT'S BONES, EVEN THOUGH IT WAS SO HARD.

  Patient problems: Foreign Body In Patient

  MAUDE report 11984861 ↗