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

Model Number	D1N20016S
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	04/23/2021
Type of Reportable Event	Serious Injury
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 in the bone and backed out after attempting to insert in the bone.During insertion of the screw the bone cracked.

• 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: 12038083
• Report Number: 0001043534-2021-00112
• Device Sequence Number: 19833615
• Product Code: HWC
• UDI-Device Identifier: 00840420120380
• UDI-Public: 00840420120380
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: D1N20016S
• Device Catalogue Number: D1N20016S
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 30 YR
• Patient Weight: 80