NA 91-14008Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04546540493675), received between Jul 14, 2023 and Jul 14, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Fracture” (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.

• MalfunctionJul 14, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE TIP OF THE DRILL BROKE OFF INTO THE PATIENT AND REMAINS IN PATIENT. THERE IS NO SIGNIFICANT SURGERY DELAY AND NO REPORTED ADVERSE EVENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17325418 ↗