The device intended for use for treatment was returned for evaluation.Nothing was identified visually that contributed to the problem.A functional evaluation was completed and the reported problem was confirmed.The handpiece test failed because the handpiece would not home.The drill guide is bent, which is causing excessive strain on the snaplock nut/worm screw assembly.This then creates a connection error when these gears lock up.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) "jamming/seizing" identified similar events.The most likely cause of this event is improper handling of the handpiece.Care and caution should be exercised during the surgical site set up and tear down to protect the handpiece from an unforeseen force, such as falling on the ground or damage during transport.Refer to the navio surgical system user's manual and the navio surgical system instrument kit cleaning and sterilization guide for proper handling.No further containment or corrective actions are recommended at this time.
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