(b)(4).This final report is being submitted to relay additional information.Investigation has determined that the reported event is a manufacturing issue and cross site investigation was carried out based on photographic evidence.Summary investigation: the manufacturing order related to involved product , lot number has been reviewed and do not show any non-conformity, rejection or concession.All the lot was accepted at the time of manufacturing.Complaint history review indicates that no additional complaint has been found which involved the affected part/lot combination.Moreover, no additional complaints have been found related to the issue description.According to gv2.24 rev.10 acondicionado de producto esteril: (packaging of sterile product), the sterile barrier is constituted by the blyster and lid, therefore the potential effect of failure sterile barrier could be compromised reported in the complaint description could not be evidenced.Although root cause has not been identified with the available information, no evidence have been identified that related the communicated event to the raw material, manufacturing or inspection of the involved part.Therefore, no corrective action or preventive action have been arisen due to the event.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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