DART-FIRE D1N20016SRecalls & 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
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00840420120380), received between Jun 21, 2021 and Jun 21, 2021 — classified as 2 injuries.
The most frequently reported specific device problem is “Failure to Advance” (2 reports).
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
- Failure to Advance2
Patient problems
- Bone Fracture(s)2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJun 21, 2021Failure to Advance; Failure to Advance
IT WAS REPORTED THAT THE SCREW WAS NOT BITING IN THE BONE AND BACKED OUT AFTER ATTEMPTING TO INSERT IN THE BONE. DURING INSERTION OF THE SCREW THE BONE CRACKED.
Patient problems: Bone Fracture(s)
MAUDE report 12038083 ↗InjuryJun 21, 2021Failure to Advance; Failure to Advance
IT WAS REPORTED THAT THE SCREW WAS NOT BITING IN THE BONE AND BACKED OUT AFTER ATTEMPTING TO INSERT IN THE BONE. DURING INSERTION OF THE SCREW THE BONE CRACKED.
Patient problems: Bone Fracture(s)
MAUDE report 12038081 ↗
Other Screw, fixation, bone devices
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- HEALIX PEEK ORTHOCORD 222205Medos International Sàrl · Screw, fixation, bone186 reports
- PRECICE® Bone Transport System STP3.5-350Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-400Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-300Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-200Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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