MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC DART-FIRE EDGE COMP SCREW HEADLESS FULL 3.0MM X 48MM; SCREW, FIXATION, BONE

Catalog Number	D0330048
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Correction to g1 (reporting contact) and h3 (device evaluated by mfg).The complaint could be confirmed, since the product was returned for evaluation and matches the alleged failure.The device inspection revealed the following: visual examination of the received product shows that the screw breakage (ductile force fracture) is the result of a combination of too much- and lateral force, clearly visible from the breakage surface as deformation, discoloration and breakage rotation lines, are visible.In addition, the tip side of the broken screw got not returned.Reporter responded: that the non-returned screw part was left in patient as the screw part does provide good compression across the joint.Further it got reported that the screw simply broke into two pieces, leaving no debris.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.Based on investigation, the root cause was attributed to a use related issue.The failure was caused by too much force in the presence of hardbone.If more information is provided, the case will be reassessed.
Event or Problem Description
It was reported that during a primary surgery, the dart fire edge screw snapped at insertion.Proximal 5mm screw fractured.The remaining screw was left in place providing good compression across the joint.Additional 3.5mm cortical and locking screws were placed in proximal end of plate.Excellent fixation was achieved.
Event or Problem Description
It was reported that during a primary surgery, the dart fire edge screw snapped at insertion.Proximal 5mm screw fractured.The remaining screw was left in place providing good compression across the joint.Additional 3.5mm cortical and locking screws were placed in proximal end of plate.Excellent fixation was achieved.
Additional Manufacturer Narrative
Analysis results are not available at the time of this report.Once the investigation has been completed any additional information will be reported in a supplemental report.

• Brand Name: DART-FIRE EDGE COMP SCREW HEADLESS FULL 3.0MM X 48MM
• 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: 21691720
• Report Number: 3010667733-2025-00362
• Device Sequence Number: 9282049
• Product Code: HWC
• UDI-Device Identifier: 00889797082501
• UDI-Public: (01)00889797082501(11)230228(17)310126(10)AF2784
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2025

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: D0330048
• Device Lot Number: AF2784
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/27/2025
• Supplement Date Received by Manufacturer: 04/01/2025
• Initial Report FDA Received Date: 03/25/2025
• Supplement Report FDA Received Date: 04/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/28/2023
• 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 Age: 65 YR
• Patient Sex: Male