(b)(4).This follow-up report is being submitted to relay additional information.Updated: b4, b5, g3, h2, h3, h6.Complaint sample was evaluated and the reported event was confirmed.Device history record (dhr) was reviewed and no discrepancies were found.The root cause is determined to be design deficiency.Visual review of the device shows nicks, gouges, and scratches to all handle surfaces.Strike plate shows indentations from previous uses.Threaded tip has fractured from the hex bolt.Fractured tip was not returned.Device has an approximate field age of 9 years.The root cause of the reported event can be traced to a design deficiency.Quality issue report previously addressed the threaded bolt fracture at root.The reduced cross-sectional thickness in the failure area is caused by the drill point that is used in the hex manufacturing.A change was implemented to increase the head height, eliminate the drill point and increase the shank fillet radius to reduce stress in the failure region.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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