(b)(4).Complaint sample was evaluated and the reported event was not confirmed.A complaint occurred because a staff member reported that the tray was compromised.This cannot be confirmed because a staff member peeled open the tray prior to returning it to biomet.Upon review, the tray displays signs of an adhesive transfer around the edges, which proves that the tray was sealed before it left biomet.However, it cannot be proved that the tray wasn't fully sealed throughout the entire distribution process because the staff member had opened up the tray.Despite all of this, the aluminum oxide pouch which contains the product is completely sealed and the part is vacuum sealed in place.As a result of this, the part is deemed sterile and can function as intended.Device history record was reviewed and no discrepancies were found.Review of the complaint history determined that no further action is required as no were trends identified.Root cause was unable to be determined, device analysis indicated that the device met specification.There are warnings in the package insert that this type of event can occur and risks are addressed in risk documentation under performance validation file #192.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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