(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, d10, g4, h1, h2, h3, h6.It was reported that the left vanguard tibial cut block would not thread onto tibial resection guide.It was determined that it was the cut block that was the issue as the right block threaded on just fine.Visual inspection confirmed the reported event.The component will not assembly with its matting instrument by using the thread which is damaged.Metal pick up is observed on the damaged 3rd and 4th threads.The root cause of the reported event could not be determined with the information provided in the complaint.The mating instrument has not been returned with the damaged component to confirm whether it is what damaged the reported event.Device history record (dhr) was reviewed and no discrepancies were found.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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