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 could support the reported complaint however, a root cause could not be determined.Production and quality testing of the handpiece was not performed as the device was not in working condition.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.Microscopic evaluation revealed minor debris within the cap and head cavities and set components.Rotor blades exhibited significant damage.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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