NA 1806-4270SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04546540196811), received between Jul 30, 2019 and Jul 30, 2019 — 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. 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 30, 2019Break; Entrapment of Device

  IT WAS REPORTED THAT, DURING A PRIMARY PROCEDURE FOR A RIGHT FEMORAL IM NAIL, AS THE SURGEON WAS DRILLING FOR THE PROXIMAL INTERLOCK SCREW, THE TIP OF THE DRILL BIT BROKE IN THE PATIENT. THE BROKEN PORTION WAS LEFT IN THE PATIENT. THE CASE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE CONSEQUENCES OR SURGICAL DELAY REPORTED. 26-JUL-19: MEDWATCH FORM (B)(4) WAS RECEIVED FOR THIS SAME EVENT AND STATED "DURING PROCEDURE THE TIP OF THE DRILL BIT BROKE OFF AND RETRIEVAL UNSUCCESSFUL."

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8843532 ↗