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

Model Number	01-020
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/12/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that an x-plate fractured around a single screw hole during screw insertion.It was noted that the screws were inserted multiple times, the caddy guide was not used, and screws were inserted free-handed into the construct.The fractured plate was removed, and another plate was implanted.There was no harm to the patient nor was there a significant delay to the procedure.
Additional Manufacturer Narrative
A review of the complaint history for the valkyrie product family shows that there have been no prior complaints regarding plate fracturing during surgery.Furthermore, no patient injury was reported, and the surgeon was able to place a new implant.An investigation of the design history record of the affected lot was completed on 7/18/2023 and the device met all specifications.The returned device was recently received.If the results of a physical evaluation change the outputs of the investigation, then a revision to this narrative will be submitted.
Additional Manufacturer Narrative
Udi related data quality updates only correct d4 content to match gudid.

• Brand Name: VALKYRIE THORACIC FIXATION SYSTEM
• Common Device Name: PLATE
• Manufacturer (Section D): J.M. LONGYEAR MANUFACTURING, LLC; 512 4th st; 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
• MDR Report Key: 17480350
• Report Number: 3014680795-2023-00004
• Device Sequence Number: 2735291
• Product Code: HRS
• UDI-Device Identifier: 00810071390531
• UDI-Public: (01)00810071390531(17)271205(10)105873(11)221205
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/08/2023

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
• Device Model Number: 01-020
• Device Catalogue Number: 01-020
• Device Lot Number: 105873
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/08/2023
• Supplement Report FDA Received Date: 12/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/05/2022
• 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: Other
• Patient Sex: Unknown