Product complaint # (b)(4).Visual inspection showed that the distal tip was fracture.Device was sent for fracture analysis.An optical image of the driver¿s fractured surface, reveals plastic deformation at the hex lobes and torsional shear markings following a circular pattern.This suggests the driver underwent a quasi-static overload torsional shear failure.No material defects or other abnormalities were observed in this analysis.A review of the device history record was conducted.No issues were identified during the manufacturing and release of this product that could have contributed to the problem reported by the customer.A trend analysis was conducted.No emerging trends were found requiring further actions.The root cause cannot be determined.However, based on device evaluation, a potential root cause may be due to wear and tear or the driver underwent a quasi-static overload torsional shear failure.As there has been no issue identified in the manufacturing or release of the device that could have contributed to the problem reported by the customer and no systemic trends were found, this complaint file will be closed with no further action required.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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