This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, d10, g4, g7, h1, h2, h3, h6, h10.Reported event was confirmed by review of pictures.Ats lab results: the fourier transform infrared spectroscopy (ftir) spectrum of the very small hair-like debris sample matches the major peaks in the ftir spectrum of skin (keratin and collagens).Device history record (dhr) was reviewed and no discrepancies were found.The likely condition of the device when it left zimmer biomet is non-conforming to specification.The root cause of the reported event is the operator not following the work instructions provided.This device falls within the scope a corrective action, the purpose of which of which is to address the issue of complaints for debris in sterile packaging.This corrective action was successfully closed in october 2019.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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