MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC DART-FIRE EDGE COMP SCREW HEADLESS FULL 2.5MM X 38MM; SCREW, FIXATION, BONE

Catalog Number	D0325038
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.Should additional information become available, it will be provided in a supplemental report.
Event or Problem Description
It was reported that during surgery the heads of two dartfire edge screws snapped off during implanting.This caused a delay in surgery because the broken head had to be removed also if there is any removal it will be a longer procedure.
Additional Manufacturer Narrative
Correction to d4(gtin) and g1(reporting contact).The complaint couldn't be confirmed, since the device was not returned for evaluation and no other evidences were provided.A review of the device history for the reported lot did not indicate any abnormalities.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.More detailed information about the complaint event must be available in order to determine the root cause of the complaint event.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
It was reported that during surgery the heads of two dartfire edge screws snapped off during implanting.This caused a delay in surgery because the broken head had to be removed also if there is any removal it will be a longer procedure.

• Brand Name: DART-FIRE EDGE COMP SCREW HEADLESS FULL 2.5MM X 38MM
• 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: cécile lefeuvre ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 21385501
• Report Number: 3010667733-2025-00161
• Device Sequence Number: 8292305
• Product Code: HWC
• UDI-Device Identifier: 00889797082464
• UDI-Public: (01)00889797082464(11)230511(17)310511(10)AF5658
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K203228
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/02/2025

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: Health Professional
• Device Catalogue Number: D0325038
• Device Lot Number: AF5658
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/20/2025
• Supplement Date Received by Manufacturer: 04/10/2025
• Initial Report FDA Received Date: 02/14/2025
• Supplement Report FDA Received Date: 05/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/11/2023
• 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
• Patient Sex: Female