MAUDE Adverse Event Report: J.M. LONGYEAR MANUFACTURING, LLC VALKYRIE THORACIC FIXATION SYSTEM; X-PLATE

Model Number	01-020
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Failure of Implant (1924)
Date of Event	02/02/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has not been returned and is not available for investigation.A dhr review was conducted or confirmed that the device(s) met specification prior to shipping.This report will be updated should this information become available at a later date.
Event or Problem Description
It was reported by a distributor that a valkyrie re operation procedure occurred in a patient.The patient was seen 11 days post operatively after experiencing a fall and coughing fit.A re operation was initiated on the patient and noted sternal dehiscence with the observation of the sternal construct failure (pull through of wires and fracture of plates).As a follow up, interview with (b)(6), pa (hcp present in the original and revision case) was conducted on (b)(6) 2023.It was noted that the patient's bone quality was extremely poor.The x-plates and the v-plate fractured at the mid-line, screws remained attached to the plates and the bone.Blunt force trauma may have contributed to the event.During the initial closure of the sternum, it was noted that the sternum bone quality was very poor.Patient received an additional procedure to remove the device, a wound vac.And muscle flap was performed.
Additional Manufacturer Narrative
Udi related data quality updates only correct d4 and g4 content to align with gudid.

• Brand Name: VALKYRIE THORACIC FIXATION SYSTEM
• Common Device Name: X-PLATE
• Manufacturer (Section D): J.M. LONGYEAR MANUFACTURING, LLC; 512 4th st; gwinn MI 49841
• Manufacturer (Section G): ABLE MEDICAL DEVICES; 512 4th street; gwinn MI 49841
• Manufacturer Contact: halie gibson ; 512 4th street; gwinn, MI 49841 ; 2316756707
• MDR Report Key: 16483153
• Report Number: 3014680795-2023-00002
• Device Sequence Number: 7738169
• Product Code: HRS
• UDI-Device Identifier: 00810071390012
• UDI-Public: (01)00810071390012(17)271111(10)105622(11)221111
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K202889
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/02/2023

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?: No
• Operator of Device: Health Professional
• Device Model Number: 01-020
• Device Catalogue Number: 01-020
• Device Lot Number: 105622
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/02/2023
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 03/03/2023
• Supplement Report FDA Received Date: 07/29/2024; 12/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/11/2022
• 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: 74 YR
• Patient Sex: Male