H10 h3, h6: the device was being used during treatment when the green dots appeared but no mesh was generated.The log files and case screenshots were returned for evaluation.The dhr was reviewed for software version and it has been validated.A complaint history review found similar complaints of the reported issue.The navio surgical system surgical technique for total knee arthroplasty contains instructions for collecting points in free collection.The relationship of the device and the reported event has been established.Case screenshots confirmed that the mesh generation problems had occurred due the surgeon collecting points only from the bone surface and not on the sides.The issue can be corrected by going back to free collection and collecting points from the sides.Therefore, the root cause of the issue was due to user error.
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