(b)(6)/ (b)(6) 2023: h4 /manufacturing date) was added.Correction - please refer to h6 clinical signs code.The reported event could be confirmed, since the lateral tibial joint line is impressed on the received x-ray.The devices were not returned for evaluation, therefore no device inspection was possible.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.The provided information was forwarded to medical affairs for review with following feedback: "the lateral tibial joint line is impressed.However, it is difficult to assess whether malunion or nonunion has occurred, here.The positioning of the plate seems to be okay.Usually, beneath the plating in these tibial head fractures (likely schatzker type ii) there is a significant loss of subchondral bone substance.If that is not addressed with either augmentation of autologous bone or bone substitute, a failure is likely.As long as we do not have additional information this cannot be assessed safely." based on the available information it is not possible to define the root cause of this event.More detailed information, like pre- and-intra operative x-rays, operation reports and patient history, about the complaint event as well as the affected devices must be available for a complete assessment.If the device is returned or if any additional information is provided, the investigation will be reassessed.
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