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	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 the bone and backing out after attempting to insert in bone.Screw is backing out post-operatively.
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.
Additional Manufacturer Narrative
Correction: b1, g1 mdr contact and reporting contact, h1, h6 health impact code.The reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.A review of the device history was not possible because the lot number was not communicated.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If the device is returned or if any additional information is provided, the investigation will be reassessed.

• Brand Name: DART-FIRE
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): WRIGHT MEDICAL TECHNOLOGY INC; 1023 cherry rd; memphis TN 38117
• Manufacturer (Section G): WRIGHT MEDICAL TECHNOLOGY, INC.; 11576 memphis arlington rd; arlington TN 38002
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 12038060
• Report Number: 0001043534-2021-00107
• Device Sequence Number: 17143952
• 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,Followup
• Report Date (Section B): 01/09/2023

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
• Device Model Number: D1N20014S
• Device Catalogue Number: D1N20014S
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/25/2021
• Supplement Date Received by Manufacturer: 01/05/2023
• Initial Report FDA Received Date: 06/21/2021
• Supplement Report FDA Received Date: 01/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 31 YR
• Patient Sex: Female
• Patient Weight: 91 KG