No product was returned; from the received photos it was noted that, there is a material transfer of outer box to tamper evident sticker and on tyvek cavity flange there is an adhesive which indicates that the tyvek lid could have been attached to the tyvek cavity flange.As it's unknown whether the tamper evident sticker was open or sealed when the customer received it, so it's unknown where the reported issue happened.Dhr 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 as the necessary information to adequately investigate the reported event was not provided.The risk of non sealed tyvek's or inner packaging is addressed in device's risk management file.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.
|