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 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.Multiple dimensions on the head and cap were checked by production personnel and all were found to be within specification.The handpiece was then microscopically evaluated by quality personnel.Both bearings looked good.Microscopic evaluation revealed damage on the rotor blades.Some rubbing marks were also seen within the head cavity.In addition, the handpiece did not meet back pressure, sound quality and cut performance specifications.
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