DART-FIRE D1N35026SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00840420120618), received between Dec 2, 2022 and Dec 2, 2022 — classified as 1 malfunction.

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

• MalfunctionDec 2, 2022Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT THE PHYSICIAN WAS USING THE DARTFIRE SCREWS AND HAD A VERY DIFFICULT TIME GETTING THEM TO BITE ENOUGH FOR FIXATION. HE ENDED UP BURNING SEVERAL SCREWS AND WAS NOT AT ALL HAPPY WITH THE RESULT. THIS CAUSED A DELAY IN OR TIME AND RESULTED IN A LESS THAN ADEQUATE CORRECTION FOR THE PATIENT. THE PHYSICIAN WAS ABLE TO FINALLY GET TWO SCREWS TO WORK CORRECTLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15910235 ↗