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.As received, the handpiece did support the reported complaint but a root cause could not be determined.There was no evidence of the cap unscrewing under testing conditions where the cap was affixed with the specified torque wrench.The issue of the cap coming off was replicated through testing but only when the cap was unscrewed by a half revolution with pressure set at 30psig.Microscopic evaluation revealed some debris and corrosion within the cap and head cavities and set components.Microscopic evaluation also revealed damage on the rotor blades.Some score marks were also seen within the head cavity.All components looked dry with no evidence of lubrication.
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