H10 h3, h6: the device was used in treatment and it was reported that the implant was not deep enough in the trochlea.Dhr review found that the software version (navio 6001) has been validated.A complaint history review identified prior similar events, 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 instructions for the user in the "recovery procedure guidelines" section.We could confirm there was a relationship established between the reported event and the device.The log files and case screenshots were evaluated.Review of the case screenshots found that the cut was according to the plan for the implant and that the system behaved as expected.The prosthesis placement screen showed that the implant was below the bone on the medial side and above on the lateral side, indicating that it needed to be rotated more for better placement and to be flush with the bone.While the side view of the implant placement did appear to be flush with the bone, it only shows the implant with respect to the medial condyle.The cut plan reflected this in the remove bone screen, where the trochlea was green, which only indicates 1mm of resection.The system behaved as expected, this was a preventable issue.The malfunction was due to a user error.
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