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

Model Number	01-050
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Code	Wound Dehiscence (1154)
Date of Event	03/03/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient who had undergone open heart surgery in (b)(6) 2024 had a reoperation in (b)(6) 2025 due to a sternal dehiscence in which a gap was identified in the bottom third of the sternum.Upon reoperation, it was observed that a single plate and screws disassociated from the bone on one side of the osteotomy.It was noted that sternal wires also pulled through the sternum.The plate did not fracture, the screws were still secured into the plate, and the plate remained affixed to one side of the osteotomy.The surgeon did not explant the subject device(s) nor was the sternum re-approximated.Additional plates and a supplemental circumferential device were implanted to stabilize the sternum.
Additional Manufacturer Narrative
This report is being submitted pursuant to the provisions of 21 cfr part 803.This report may be based on information that has not been able to be completely investigated or verified prior to the required reporting date.This report does not reflect a conclusion that the report constitutes and admission that the device, the company, or its employees caused or contributed to the potential event described in this report.As of the date of this report, the device has not been returned to the manufacturer for evaluation.A definitive root cause cannot be determined.If additional information relevant to the investigation or other content of this report is identified, this report will be updated.Multiple mdr reports were filed for this event, please see associated reports: 3014680795-2025-00021, 3014680795-2025-00022, 3014680795-2025-00023, 3014680795-2025-00024.

• Brand Name: VALKYRIE THORACIC FIXATION SYSTEM
• Common Device Name: BOX PLATE
• Manufacturer (Section D): J.M. LONGYEAR MANUFACTURING, LLC; 512 4th st; gwinn MI 49841
• Manufacturer (Section G): J.M. LONGYEAR MANUFACTURING, LLC; 512 4th st; gwinn MI 49841
• Manufacturer Contact: wade depas ; 512 4th st; gwinn, MI 49841 ; 9063795322
• MDR Report Key: 21740780
• Report Number: 3014680795-2025-00020
• Device Sequence Number: 8789918
• Product Code: HRS
• UDI-Device Identifier: 00810071390562
• UDI-Public: (01)00810071390562(17)290507(10)109038(11)240507
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K232515
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/01/2025

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: 01-050
• Device Catalogue Number: 01-050
• Device Lot Number: 109038
• 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: 03/03/2025
• Initial Report FDA Received Date: 04/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/07/2024
• 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: Hospitalization; Required Intervention
• Patient Age: 76 YR
• Patient Sex: Unknown
• Patient Weight: 89 KG