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 not able to verify the complaint.The returned handpiece was tested by manufacturing personnel and did not meet specification criteria for speed control, cut and noise performance.Quality personnel then investigated the handpiece.The handpiece exhibited maximum temperature of 26.7°c during free run testing.Per iso 13732-1, this temperature level does not qualify as a burn regardless of the contact period.The handpiece was not cutting as received.Poor lubrication practices of the head cavity most likely caused lodging of the cap end bearing inside of the cap which led to set instability.This frictional contact most likely led to the heating of the cap area, failure of all cut testing and horizontal wear/cracking of the cap end bearing retainer.All components looked dry with no sign of lubrication present.
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