This follow-up report is being submitted to relay additional information.One fractured screw was returned.The fracture is of the bone thread and occurred below the second full thread from the thread runout.There is no other significant markings or anomalies that can be seen on the returned screw.Photos were supplied via email that show various fractured screws but, it is unknown which photo pertains to subject complaint so no information can be gained by the review.Lot identification is necessary for review of device history records, lot identification was not provided.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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