(b)(4).Complaint sample was evaluated and the reported event was confirmed.The device was returned in its packaging, and visual inspection found that the sterile inner poly bag was melted to the tyvek pouch.Device history record (dhr) was reviewed and no discrepancies were found.A specific root cause of the reported event cannot be determined.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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