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

Model Number	01-3013-4-HA
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Wound Dehiscence (1154)
Date of Event	08/27/2024
Type of Reportable Event	Serious Injury
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: 3014680795-2024-00015; 3014680795-2024-00016; 3014680795-2024-00017; 3014680795-2024-00019.
Event or Problem Description
It was reported that a patient who underwent sternal closure using a variety of plates and screws along with stainless-steel suture in (b)(6) 2024 experienced a sternal dehiscence after an extreme coughing fit.It was also reported that the plates and screw construct remained intact, but pulled away from bone, and the stainless-steel suture pulled through the sternal tissue.The patient underwent revision surgery to correct the dehiscence.
Additional Manufacturer Narrative
Udi related data quality updates only correct h4 and h5 content to match gudid.

• Brand Name: VALKYRIE THORACIC FIXATION SYSTEM
• Common Device Name: SCREW
• 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
• MDR Report Key: 20325944
• Report Number: 3014680795-2024-00018
• Device Sequence Number: 7669597
• Product Code: HWC
• UDI-Device Identifier: 00810071390685
• UDI-Public: (01)00810071390685(17)280209(10)106274(11)230209
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K232515
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/27/2024

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: 01-3013-4-HA
• Device Catalogue Number: 01-3013-4-HA
• Device Lot Number: 106274
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/03/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/27/2024
• Supplement Report FDA Received Date: 12/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/09/2023
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 65 YR
• Patient Sex: Male