H3, h6: the navio surgical system japan, pn: rob00043, sn: (b)(6) used in treatment was not returned to the designated complaint unit for evaluation, therefore, visual and functional inspections could not be performed.The software files were downloaded from the device and provided for investigation, however they did not contain any data and therefore could not be reviewed.It is possible that the files were not correctly copied onto the usb prior to sharing for investigation.Although the reported tibia baseplate halation on the planning screen could not be confirmed, it is possible that this is a known software bug, where the block model of the tibia is visible in certain implant positions on the planning screens.This can be corrected by translating or rotating the implant by 1 click.After translating/rotating the implant, the block model may appear again if the implant is moved back to that specific orientation.The navio surgical technique guide for knee arthroplasty (500200) provides guidelines for recovering to a fully manual procedure in the ¿recovery procedure guidelines.¿ this situation is captured in the risk assessment released at the time of the complaint.The failure mode and associated risk have been anticipated within the risk file and that the documented risk level is still adequate.A review of manufacturing records indicate the software met all specifications upon release into distribution.A complaint history review found similar reports.A review of prior escalation actions was performed and found no actions that are applicable to the scope of the reported complaint.This issue will be continuously monitored through complaint investigation and post market surveillance.Based on the investigation, no containment or corrective actions are recommended at this time.
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