The reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided.Upon further investigation by the prophecy team, the following was noted: the ct scan was processed within normal, acceptable ranges.No errors were identified during the segmentation procedure.A loose body osteophyte was found on the distal tibia.This body was segmented according to the procedure, and it was recommended to be removed prior guide placement.The alignment guides were designed within normal, acceptable ranges.No abnormalities in the internal process were found.The engineering drawings and quality documents were processed within normal, acceptable ranges.No abnormalities in the internal process were found.It was not possible to identify what caused the tibia prophecy block inaccuracy mentioned in the complaint¿s email.A potential root cause may be a discrepancy in user expectations vs guide fit and feel during surgery or user error during surgery.Another potential root cause could be that the loose osteophyte at the tibia was not properly removed, which might have had an impact on the guide reference.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.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.If the device is returned or if any additional information is provided, the investigation will be reassessed.
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