Skip to content

DART-FIRE D1N30016SRecalls & reported problems

Wright Medical Technology, Inc. · Headed Compression Screw · Class 2 · Implant

All models of DART-FIRE (11)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
2
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00840420120311), received between Jun 21, 2021 and Jun 21, 2021 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Difficult to Advance” (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

Device problems

  • Difficult to Advance1
  • Failure to Advance1

Patient problems

  • Bone Fracture(s)1
  • No Clinical Signs, Symptoms or Conditions1

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 12038084 ↗
  • InjuryJun 21, 2021Difficult to Advance; Difficult to Advance

    IT WAS REPORTED THAT THE SCREW WOULD NOT PURCHASE IN THE BONE AND BACKED OUT AFTER ATTEMPTING TO INSERT IN THE BONE. THE PATIENTS BONE CRACKED AND THE SURGERY WAS DELAYED.

    Patient problems: Bone Fracture(s)

    MAUDE report 12037885 ↗

Other Screw, fixation, bone devices

All Screw, fixation, bone devices →

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page