(b)(4).This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was confirmed.The lower cylinder was not well screwed to the upper cylinder, consequently the vacuum did not hold, which caused the monomer failure to enter the cylinder.The review of the device manufacturing quality record indicates that (b)(4) products optipac-s 60 refobacin plus bone cement, reference (b)(4), lot number a727c07085 were manufactured on 05 january 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 which could be linked to the event described in the complaint.No similar complaint has been recorded for optipac-s 60 refobacin plus bone cement, reference (b)(4), lot number a727c07085 within one year.Investigation concluded that the reported event was likely due to handling error.A summary of the investigation was sent to the complainant conveying zimmer biomet conclusions and asking customer to refer to instructions for use.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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