The device was intended for use in treatment and it was reported that one of the handpiece thumbscrews was broke while tightening the clamshell.Dhr review found that no conditions which could contribute to the reported event were identified.This reasonably suggests that the device met the specifications at the date when it was released to distribution.A complaint history found similar reports, this issue will continue to be monitored.We could not confirm if there was a relationship established between the reported event and the device.Photos of the device were not provided for evaluation and the device was not returned.Review of the information provided in the field report and the complaint evaluation form revealed that the user had no extra thumbscrews, so they used coban elastic tape to keep the handpiece closed.Also, report indicates that the screw was broken during tightening, over-tightening being the typical cause of broken thumbscrews.The root cause was established to be undetermined after investigation.
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