(b)(4) updated: b4, b5, d10, g4, h1, h2, h3, h6, and h10 reported event was considered confirmed via visual evaluation of the returned product identified that there is debris inside the sterile package.Ats also conducted a ftir analysis which stated the ftir spectrum of the very small hair-like debris sample matches the major peaks in the ftir spectrum of a polyamide like sylvamid.Device history record was reviewed and no discrepancies relevant to the reported event were found.The root cause of the reported event can be attributed to the operator not following instructions during manufacturing.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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