It was reported that during a navio assisted tka surgery when initially burring distal medial femur, the surgeon did not think the cut was accurate.The distal medial femur on the software displayed that there was more bone to burr (purple, blue and green) on the anterior portion of the distal medial cut.The software also displayed that the plan was achieved (white) on the posterior portion of the distal medial cut.The surgeon did not agree with this and said that the anatomy showed that it was the opposite, no more bone needed to be cut on the anterior portion of the distal medial cut and more bone needed to be cut on the posterior portion of the distal medial cut.Since the surgeon did not believe this was accurate, the surgeon asked for the handpiece to be checked.The tech evaluated the handpiece assembly to check again that it was properly assembled, and then the handpiece was re-homed.The checkpoints for the bone arrays were checked and they both passed.The visualization tool was then used and put over the portion of the distal medial cut that was burred, and the visualization tool showed that the cut was not to plan.The bone model was refreshed and the surgeon then refined the bone on the distal medial femur away, and he stated that what the software was saying to cut was still not accurate with the bone he needed to remove on distal medial femur.The procedure was completed, with a non-significant delay, using manual instrumentation with the desired outcome (no additional unintended cuts due to this issue).Patient was not harmed beyond the problem reported.
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H3, h6: the navio surgical system us, npfs02000, (b)(6), used for treatment was not returned for evaluation, therefore a visual or functional inspection could not be performed.The reported problem could not be visually or functionally confirmed.The log files and/or screenshots were provided to the designated complaint unit for evaluation, and the review of the log files concluded that the system was functioning as intended.The surgeon¿s resection numbers and implant positioning relative to the mapped surface looked appropriate.It could not be confirmed that the cut was not to plan or that the visualization tool showed an inaccurate cut.Although the reported problem was not confirmed through a visual or functional evaluation, factors that may have contributed to the reported symptom may have been associated with defining incorrect posterior points, or possible under sizing on the femur.Software version rc-7007 has been validated on test report tr1614.A review of manufacturing records indicates the software met all specifications upon release into distribution.A complaint history review for similar reported/confirmed complaints found similar events.A historical capa, nc, hhe/pra, field action review could not be completed.The product was not returned, and no evidence was made available to link the complaint to a capa, nc, hhe/pra, field action.If a navio¿ surgical system failure occurs at any point during the surgical case, refer to the surgical technique guide for knee arthroplasty, recovery procedure guidelines tables for proper guidance regarding recovering to a fully manual procedure.A failure can consist of, but is not limited to, a system software crash, unrecoverable hardware failure, handpiece failure with no backup available, tracker array failure or loss of contact with bone that is unrecoverable, etc.The failure mode and associated risk have been anticipated within the risk file and the documented risk level is still adequate.Although no further containment or corrective action is recommended or required at this time, the failure mode will continue to be closely monitored through complaint investigation and trended through post market surveillance activities.
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