The reported event could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.The device inspection was not possible as the product was not returned for investigation.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.Upon further investigation of the ct scans by healthcare professionals the following was observed "full tar (construct): there is a girdlestone situation visible in the upper ankle joint.A significant bone defect is present in the tibia as well as in the talus.There is also a consolidated superparticular distal tibia fracture visible which is consolidated and addressed with a medial plate.Without any further information it can be assumed, that an infection took place and may have led to failure and the need to revise.As the time span between the fracture (12/5/23) and the infection is below 3 months, there is a chance, that the infection is due to the revision and implantation of the plate, however, it is not likely related to the implant.Therefore, the event is potentially user, but not device related." the failure is most likely caused by infection and bone defects in tibia and talus.However, more detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.Furthermore, our healthcare professional opined that the time span between the fracture ((b)(6) 2023) and the infection is below 3 months, there is a chance, that the infection is due to the revision and implantation of the plate, however, it is not likely related to the implant.If device is returned or any further information is provided, the investigation report will be reassessed.
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