Based on all the available information, boston scientific determined the most probable cause of the event was related to an unintended user error.The clinical observations were confirmed through laboratory analysis as the setscrew was stuck in the up position against the retaining washer, and the force required to loosen the setscrew was greater than the force that would be exerted by the torque wrench packaged with this device.The instructions for use (ifu) provides additional instructions on how to loosen stuck setscrews if they occur during procedures and reminds users not to back the setscrew out against the backstop.
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