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.Initial observations supported the reported complaint.Production and quality testing of the handpiece was not performed as the device came in missing a cap and cartridge.Multiple dimensions on the head were checked by production personnel and all were within specifications.Dentsply is unable to determine how the cap might have come unscrewed as all handpieces are 100% performance tested prior to shipping.
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