It was reported that at the start of ukr case, had trouble collecting hip center due to the patient's bmi.Also had a very hard time collecting the last bar of the unstressed range of motion and collecting a point in the last third of the stressed range of motion.The lowest that could get on the hip center was 1.4, so took that and moved forward.The patient's anatomy proved for a difficult gap planning too, especially due to flexion contracture and tightness in extension.The patient then drastically loosened towards terminal flexion.Moved into burring and the surgeon looked it was off the bone on the posterior femur, but took bone.Then moved to the tibia and finished that burring without incident.Then moved back to the femur, started with the anterior lug hole.Once it was blurred, saw that the hole was on the very edge of the medial condyle and surgeon decided to complete procedure with manual instrumentation.
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The device was used during treatment when the user had trouble collecting hip center.The log files and case screenshots were returned for evaluation.Dhr review found that the software version (navio rc-6103) had been validated.A complaint history review found similar complaints of the reported issue and it will continue to be monitored.This failure has been identified in the risk file.The surgical technique guide released at the time of the complaint (pn 500097) provides instructions on hip center calculation.The relationship of the device and the reported event has been established.Review of the log files did not show any movement of the trackers and there were no checkpoint verification errors.Factors that could have contributed to the reported event were that the surgeon was gripping the handpiece tracker hard enough to bend it, causing the discrepancy between the physical cut and the cuts shown on the system.Additionally, in-house testing was performed while gripping the tracker and was able to bend it enough to receive similar results as in this case.This can also be amplified if the tracker is slightly loose, but can still happen when the tracker is clamped down relatively tightly.It was recommended to the user that in the current software version, one can check if the tracker is inaccurate during cutting by touching the pointer probe tip to the bur tip.The tools-eye view should verify that they are touching in software.If they run across this issue again, they should do that to verify that the handpiece tracker is not loose or distorted.Therefore, the root cause of the reported event was due to user error.Per complaint details, this represents a procedure complication and does not represent a device malfunction.The patient's body habitus made collecting hip center difficult, the patient's anatomy made for a difficult gap planning also.The surgeon decided to complete procedure with manual instrumentation.Based on the information provided, the navio was abandoned for manual instrumentation and the patient injury/impact beyond the reported events could not be concluded.Therefore, no further medical assessment is warranted at this time.
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