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); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/29/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent a revision procedure due to evidence of sternal instability following a severe coughing fit.It was observed that sternal wires had pulled through the bone and an x-plate had fractured at a single location.It was noted that the screws were still securely locked into the plate as well as fully intact to bone substrate.The device was explanted, retained by the hospital, and sent back to the manufacturer for further investigation.A new device was implanted to re-close the chest-wall and there was no further harm to the patient.
Additional Manufacturer Narrative
An investigation of the design history record of the affected lot was completed on (b)(6) 2023 and the device met all specifications.Upon review of the returned device, there were no visible signs that would indicate a product defect or nonconformity.
Additional Manufacturer Narrative
Udi related data quality updates only correct d4, h4, h5 content to match gudid.

• Brand Name: VALKYRIE THORACIC FIXATION SYSTEM
• Common Device Name: X-PLATE
• Manufacturer (Section D): J.M. LONGYEAR MANUFACTURING, LLC; 512 4th street; gwinn MI 49841
• Manufacturer (Section G): ABLE MEDICAL DEVICES; 512 4th st; gwinn MI 49841
• Manufacturer Contact: halie gibson ; 512 4th st; gwinn, MI 49841 ; 2316756707
• MDR Report Key: 17863579
• Report Number: 3014680795-2023-00005
• Device Sequence Number: 5730019
• Product Code: HRS
• UDI-Device Identifier: 00810071390531
• UDI-Public: (01)00810071390531(17)271208(10)105871(11)221208
• Combination Product (Y/N): N
• Initial Reporter State: NE
• 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: Other
• Initial Reporter Occupation: Administrator/Supervisor
• Remedial Action: Replace
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/03/2023

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: 105871
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 10/03/2023
• Supplement Report FDA Received Date: 07/29/2024; 12/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/08/2022
• 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 Sex: Male
• Patient Weight: 242 KG