It was reported that during a replacement surgery, the surgeon attempted to screw in the setscrew on the new generator with two separate screwdrivers, but he could not get the screw to click.The septum plug and screw then proceeded to fall out of the generator, so they had to implant a new generator.Reportedly, the set screw was turned in the correct direction, but it would not engage from the very first turn.There was no clicking sound at all and it wouldn¿t hold the lead securely in place.The suspect product was returned but product analysis has not been completed to date.No further relevant information has been received to date.
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Product analysis was completed on the returned generator on.Analysis found that the header septum cavity and the septum met dimensional specifications.Examination of the set screw identified indentation marks at the bottom of the set screw which shows that a lead pin or test resistor was secured with the returned set screw.Furthermore, the hex head was damaged with the hex socket rounded out, which can occur when the torque wrench is not fully engaged into the hex head.This damaged hex head would prevent the tightening of the set screw on the lead pin or the test resistor and may have contributed to the detachment of the set screw.No further anomalies were identified.No further relevant information has been received to date.
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