Though no medical/surgical intervention was required to preclude a serious injury in this event, there have been previously reported events involving a similar device that resulted in the need for medical/surgical intervention to preclude permanent damage to a body structure or permanent impairment of a body function.Therefore, this event meets the criteria for reportability per 21 cfr part 803.Dentsply was able to verify the complaint as the temperatures during quality testing did exceed maximum temperature.The returned attachment was tested by manufacturing personnel and met all production specification.Quality personnel then investigated the attachment.The attachment maximum temperature while under load testing with coolant spray on was 60.4°c.The attachment was then disassembled and microscopically evaluated.Microscopic evaluation revealed minor gear wear on the head-tail and head assemblies.Cap and head cavities and inner components appeared to be dry with minor debris.There was also evidence of the set coming into contact with the interior of the cap cavity during use.This indicates severe interaction at high rotational speeds between these two mechanisms which creates heat.The lack of lubrication may also have caused friction and as a result increase the temperature causing heat reported in the complaint.
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