Follow-up #1 and final report submitted to update sections catalog #, based on the results of investigation.During drilling of the in wound femoral pin (4x 140 pin) the distal anterior portion of the femur fractured.The tka was aborted.The product was unavailable for inspection as the product was not returned.Unable to perform as the lot number was not provided.Unable to perform as the lot number was not provided.Product was unavailable for inspection and lot information unavailable for device history review.User manual identifies predrilling of hard bone may be required and sites publications which support the potential for risk of fracture near the bone pin sites.Based on users experience, this failure mode is a knowledge based error.A review of stryker¿s nc/capa database indicated there have been 0 ncs and capas associated with the product and failure mode reported in this event.Device not returned.
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