Though no med/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 med/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.Damage was found in the head threads and rubbing marks were observed within the head cavity.The handpiece failed all production requirements.
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