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.The complaint could not be verified as the handpiece was not operative as received.The handpiece was microscopically evaluated.The burr end bearing was found dislodged from the set assembly and stuck within the head cavity.The rotor blades did not come into contact with the inside surface of the head cavity.Score marks were observed on the cap side of the set assembly and cap and head cavities.Minor debris was observed within the cap and head cavities.Bur end bearing failure could have increased vibration within the head cavity causing the cap to unscrew, but this could not be confirmed.The threads and depth of both the cap and head of the returned handpiece were measured.The head depth did not meet specification.
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