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.The returned attachment was tested by quality personnel.The attachment maximum temperature while free running with coolant spray off after 30 seconds was 44.1°c and 95.0°c after 1 minute and 57 seconds.These temperatures did exceed specification and generate the heat noted in the complaint.Cap end bearing failure, free roaming ball bearings and excessive debris most likely created friction within the head which resulted in temperature increase.
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