H10: the device was used in treatment.Case log files and screenshots were returned for evaluation.Dhr review found that the software version 6.0.01 has been validated.A complaint history review identified similar events, this issue will continue to be monitored.This failure is an identified failure mode within the risk file.The navio system instructions for use released at the time of the complaint (b)(4) provides instructions for the user that "if at any point during the procedure, you observe that the handpiece tracker frame has become loose, tighten the tracker frame to the handpiece and recalibrate the handpiece.We could confirm there was a relationship established between the reported event and the device.Review of case screenshots noted that the femur checkpoint had moved 6.7mm.This was found at checkpoint verification after cutting the femur, before cutting the tibia.The distance of 6.7mm could indicate that the tracker rotated from an edge to a flat.The user likely thought that the tracker did not move because everything could have looked fine visually and it depends when the tracker moved.The tracker could have rotated from the edge to the flat from the vibrations from burring the femur or when the cut block was impacted, or the tracker could have been bumped slightly after the user finished cutting and switched to using the plate probe for visualize cut.While the tracker may seem tight and rigid even if it is tightened on an edge, it can still move to a flat during the case.Case screenshots also showed that the holes for the cut block were not completely burred and still showed green portion to cut.It is recommended to switch to the 2mm bur to fully bur the holes.Fully burring these out will create a better and easier fit of the guide.Per complaint details, the device malfunctioned during use and the navio was abandoned for manual instrumentation.Based on the information provided the modified procedure did not result in patient injury/impact; therefore, no further medical assessment is warranted at this time.
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