It was reported that the handpiece went down.The drill would not retract or home.It is acted, as it was jammed.We were able to get through retract, calibrate, and homing error was shown on the screen.The handpiece was replaced in order to start the case.The device was not being used with a patient during the event.Results of the investigation have concluded that the snaplock assembly was damaged, which makes it a reportable event.
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H10: the navio handpiece (part number 110137 / serial number (b)(6)), intended for use in treatment, had homing failure prior to a procedure on (b)(6) 2015.The navio handpiece was not returned for further evaluation and a visual/functional inspection could not be performed.During an internal analysis, the problem was determined to be caused by the material used to manufacture one of the snap lock components.The material used by one of the suppliers is displaying properties after autoclave sterilization that may cause the snap lock assembly to become tight.This handpiece had a snap lock from one of the affected lots.The root cause of this issue was found to be supplier/raw material fault.A device history record review found no conditions which could contribute to the reported event and the device met all manufacturing specifications during release for distribution.A complaint history review found similar reports and this issue will continue to be monitored.
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