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

Model Number	D1N30018S
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	05/13/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device not returned at time of this report.If additional information becomes available, it will be provided on a supplemental report.Device not returned at time of report.
Event or Problem Description
It was reported that the screw would get purchase into the patient's bone and would back out after attempts to insert.The surgeon had to used excessive force during insertion which caused the cracking of the bone cortex.The cracking of the bone caused a delay in surgery.

• 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: 11962521
• Report Number: 0001043534-2021-00097
• Device Sequence Number: 1321996
• Product Code: HWC
• UDI-Device Identifier: 00840420120342
• UDI-Public: 00840420120342
• 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
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/08/2021

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: D1N30018S
• Device Catalogue Number: D1N30018S
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/13/2021
• Initial Report FDA Received Date: 06/08/2021
• 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: Other
• Patient Age: 27 YR
• Patient Weight: 58