No fault could be found with the returned navigation unit.The navigation unit powered up and successfully passed horizontal, vertical, and side calibration.The unit also successfully completed multiple simulated maneuvers during testing.The navigation unit was found to function as design.A review of the log files revealed the numbers were as described.The root cause of the failure was found to be a rare timing issue in when the values were being saved on the measurement screen.The correct numbers were shown to the user during measurement.A review of the device history record (dhr) was conducted.The device passed all manufacturing specifications prior to release.Orthalign, inc.Will continue to monitor this issue and take action if action limits are exceeded.
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