DART-FIRE D1N30018SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00840420120342), received between Jun 8, 2021 and Jun 21, 2021 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Difficult to Insert” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 21, 2021Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT THE SCREW WAS NOT BITING THE BONE AND BACKING OUT AFTER ATTEMPTING TO INSERT IN BONE. THERE WAS A DELAY IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12038059 ↗
• InjuryJun 8, 2021Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE SCREW WOULD GET PURCHASE INTO THE PATIENT'S BONE AND WOULD BACK OUT AFTER ATTEMPTS TO INSERT. THE SURGEON HAD TO USED EXCESSIVE FORCE DURING INSERTION WHICH CAUSED THE CRACKING OF THE BONE CORTEX. THE CRACKING OF THE BONE CAUSED A DELAY IN SURGERY.

  Patient problems: Bone Fracture(s)

  MAUDE report 11962521 ↗