(b)(4).Report source, foreign - event occurred in (b)(6).The device was not returned to the manufacturer.Therefore it could not be analyzed.The review of the device manufacturing quality record indicates that 292 products biomet bone cement 2x40g, reference 3003940001, batch a750ec2201 were manufactured on 07 august 2018.The device manufacturing quality record indicates that the released product met all requirements to perform as intended.No non conformity or deviation was observed.The review of the sterilization certificate indicates that the products were sterilized according to the specification.2 complaints have been recorded for batch a750ec2201 on the reported event within one year.According to available data, the most probable root cause is due to packaging issue (sealing process).Corrective action has been initiated to address reported 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.
|