Visual, dimensional, functional and material analysis could not be performed as the device was discarded.A review of the device and complaint history records could not be performed as a valid lot number was not provided and could not be obtained.Per surgical technique: once the construct is finally tightened, the blades can be removed.Slide the blade remover, with the arrow on the blade remover pointing away from the center of the blades, down over one of the blades.In the direction of the arrow, apply a force to break the blade off of the screw head.The blade remover will retain the blade within the instrument.With the blade remover outside of the wound, slide the button down to eject the blade.Repeat for the remaining blades.The tab fracture at unintended location was noticed a few days after the initial surgery.Fractured tab was not returned as it was discarded by customer.It is unknown if the blade remover was properly seated onto blade during initial surgery.Root cause could not be determined conclusively but most likely due to 'user does not use enough angling of blade remover or uses wrong direction; user does not fully seat instrument on blades - applies load on weld; user does not engage retention mechanism to hold blade.'.
|