H10 h3, h6: the device was being used in treatment and was not made available to the designated complaint unit for investigation.Thus, visual and functional investigation could not be performed.Dhr review found that the device met manufacturing specifications.A complaint history review found similar reports, this issue will continue to be monitored.This failure is an identified failure mode within the risk file.The surgical technique guide released at the time of the complaint provides information regarding tibial alignment guide assembly in the "tibial preparation" section.A relationship between the device and the reported event could not be established.
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