Though no medical/surgical intervention was required to preclude a serious injury in this event, there have been previously reported events involving this 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.The returned handpiece was tested and did not meet production specifications for speed control and cut performance.It was also noted by manufacturing personnel that the cap is heating up.Quality personnel then investigated the handpiece.The handpiece exhibited maximum temperature of 58.5 degrees celsius during free run testing and 59.7 degrees celsius during load testing.Poor lubrication practices of the head cavity most likely caused lodging of the outer race of the set 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 ball pocket wear/cracking of the cap end bearing retainer.All components looked dry with no sign of lubrication present.
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