The device used for treatment was returned for evaluation.The reported problem was visually confirmed.The snap locknut is broken, prohibiting the snap lock movement along the lead screw.Snap lock is an older style (without pin).The functional evaluation could not be performed due to the broken snap lock nut.A review of manufacturing and service records indicate the device met all specifications upon release into distribution.A complaint history review for similar reported/confirmed complaints associated with the handpiece and failure mode(s) "doesn't work" identified similar events.The most likely cause of this event is the mechanical failure of the snap lock.As a part of corrective actions, more robust design of the snap lock has been released.
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