The reported navio handpiece, used in treatment, was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional evaluation could not be performed.A device history record review was not performed since there was no part/serial/lot number provided and it could not be concluded if the device met the manufacturing specifications.A complaint history review found 30 similar reports and this issue will continue to be monitored.A relationship, if any, between the subject device and the reported event could not be determined.A factor that could have contributed to the reported event would be if the handpiece motor had seized after sterilization, causing the higher torque.No containment or corrective actions are recommended at this time.If the product associated with this event is returned at a future date, this evaluation will be reopened for investigation.
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