MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY, INC. DART-FIRE; SCREW, FIXATION, BONE

Model Number	D1N20014S
Medical Device Problem Codes	Difficult to Advance (2920); Migration (4003)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned.If additional information becomes available, it will be provided on a supplemental report.
Event or Problem Description
It was reported that the screw was not biting the bone and backing out after attempting to insert in bone.Screw is backing out post-operatively.

• Brand Name: DART-FIRE
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): WRIGHT MEDICAL TECHNOLOGY, INC.; 11576 memphis arlington rd; arlington TN 38002
• MDR Report Key: 12038046
• Report Number: 0001043534-2021-00105
• Device Sequence Number: 4000604
• Product Code: HWC
• UDI-Device Identifier: 00840420120328
• UDI-Public: 00840420120328
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K082320
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: D1N20014S
• Device Catalogue Number: D1N20014S
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/25/2021
• Initial Report FDA Received Date: 06/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 31 YR
• Patient Weight: 91