(b)(4).(b)(6).The device has been returned to the manufacturer.After evaluation it has been that the inner sterile packaging was damaged.The packaging missing event could not been confirmed.Indeed, the device history record has been reviewed.No discrepancies were found.With the available information, the exact root cause of the event could not be determined.However, a corrective action has been initiated to address the damaged inner sterile packaging issue.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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