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 reported complaint.There was no evidence of the cap unscrewing under testing condition where the cap was affixed with the specified torque wrench.The cap only moved (tighter back onto the cap) when it was unscrewed by half a revolution during testing.As received, the handpiece was functioning and the cut quality was good.Microscopic eval revealed debris within the cap and head cavities.Some rubbing marks were also seen within the head cavity.Multiple dimensions on the head and cap were checked.The head threads were found to be out of specification.
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