It was reported that during a surgical procedure, a "handpiece exposure control motor failure" warning appeared multiple times when at the point of pressing cut femur on the burring screen.Handpiece continued to pass validation and homing steps which had to do multiple times to stay in the workflow.A second handpiece was opened and set up with the same result.For the exercise, a second drill was set up as well.No clamps were used on the cables thus broken cables not an issue.The surgeon decided to use manual instrumentation, no patient injuries reported beyond this event.Results of investigation have concluded that there was an over current error that was caused by the siu, there was no problem found with the handpiece.The over current failure is a problem in the siu that randomly causes handpiece disconnect errors, which makes it a reportable event.
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H10 h3, h6: the device was used during treatment but only the log files were returned for a prior investigation.The initial visual evaluation was performed by reviewing the returned log files which found that an "over current" error had occurred.When the error can only be cleared by rebooting the system, it is indicative of an issue in the siu firmware that randomly causes the handpiece error message and is not indicative of an issue with the handpiece.The errors occurred on two different handpieces and therefore this confirms the issue in the siu.There was no serial number provided for the dhr review of the siu so it could not be concluded if the device met the manufacturing specifications.A complaint history review found similar reports of the issue.This issue will continue to be monitored.The surgical technique guide released at the time of the complaint provide instructions troubleshooting information on the navio surgical system.This failure has been captured in the risk profile.The relationship of the device and the reported event has been established.The over current error that occurred was due to an issue in the siu.As a result, the root cause of the reported event was due to an electrical component failure.
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