The navigation unit's event log was examined for the phenomenon reported in the complaint description.No flexion values were reported to have approached 18 degrees, though there was an issued observed during the femoral resection in general.The logged snapshot of resection values did not change between each snapshot, though it is expected that they would change in some minor degree between samples.The issued observed occurred after a period of reported instability on the reference sensor.The same phenomena occurred during the tibial resection as well.An attempt to reproduce this behavior in-house was unsuccessful for both femoral and tibial resections.It is unclear as to what was causing the bouts of instability; the reference sensor would be needed for further information but was unavailable for return.While the values reported in the complaint description cannot be found within the event log, the complaint can still be confirmed based on the other evidence present due to the issue regarding the resection angles not updating between samples.There was no patient consequence reported as a result of the event.A review of the device history record (dhr) was conducted.There was 1 process deviation (pd) within the dhr.The pd is 1480.There were no nonconforming material reports (ncmrs) within the dhr.The device passed all manufacturing specifications prior to release, and it is concluded that the issue in pd1480 did not contribute to the reported complaint.
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