The device was being used during treatment and was not returned for evaluation.There was no serial number provided for dhr review so it could not be concluded if the device met the manufacturing specifications.A complaint history review was performed and found 17 reports of the issue.This issue will continue to be monitored.The surgical technique guide released at the time of the complaint (pn 500095 rev#d) provides instructions on how to recover to a fully manual procedure in the case the of a navio surgical system failure at any point during the surgical case.A failure can consist of, but is not limited, a system software crash, unrecoverable hardware failure, handpiece failure with no back available, tracker array failure or loss of contact with bone that is unrecoverable., etc.Since the reported event was related to a component failure, there is no indication in this complaint that the user did not follow the ifu.A relationship between the device and reported event has not been established.A factor that could have contributed to the reported event was a short in the handpiece cabling that caused a blown fuse in the siu.However, without the device for evaluation, the reported event cannot be confirmed.Therefore, the root cause of the reported event could not be determined.If the product associated with this event is returned at a future date, this evaluation will be reopened for investigation.Without supporting clinical/medical documents, a thorough investigation cannot be performed.There was no major delay and therefore, no patient injury/impact to the patient; therefore, no further medical assessment is warranted at this time.
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