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 reported complaint was verified through testing.The returned handpiece was tested by manufacturing personnel and did not meet production specification for cut performance.It was also noted by manufacturing personnel that the handpiece was heating up.Quality personnel then investigated the handpiece.The maximum temperature of the handpiece while free running was 48.3 c.Per iso (b)(4), this temperature level does not qualify as a bum regardless of the contact period but was higher in temperature than a new handpiece.Poor lubrication of the head cavity most likely caused lodging of the cap end beating 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 beating retainer.All components looked dry with no sign of lubrication present.
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