(b)(4).Report was previously submitted incorrectly under report number: 0001822565 -2017-06510.Complaint sample was evaluated and the reported event was confirmed.Visual inspection of the returned packaging confirmed that the drill bit is missing from the package as reported.Device history record was reviewed and no discrepancies were found.The root cause of the reported event is attributed to manufacturing deficiency.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.
|