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.There was no evidence of the cap unscrewing under testing conditions where the cap was affixed with the specified torque wrench.The cap only moved when it was unscrewed by half a revolution during testing.Bur end bearing was missing as received.Microscopic evaluation revealed wear on the rotor blades.Some rubbing marks were observed within the head cavity.Significant damage was also observed within the head cavity.Significant debris was found inside of the head and cap cavities.Multiple dimensions on the head and cap were checked by production personnel.The head depth did not meet specification.
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