(b)(4).(b)(6).The device was not evaluated as the batch number was not communicated and the product was not returned.The device will not returned to the manufacturer.Therefore it could not be analyzed.The device manufacturing quality record could not be reviewed as the item and lot number of the product were not communicated.With the available information, the exact root cause of the event could not be determined.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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(b)(4).This follow-up report is being submitted to relay additional information.The following section has been updated : b5, g1-2, g4, h2, h3, h6, h10.The device was not returned to the manufacturer.Therefore it could not be analyzed and the reported event could not be confirmed.The device manufacturing quality record could not be reviewed as the item and lot number of the product were not communicated.The reference and batch of the semi-finished product optipac monomer pouch 15ml, reference (b)(4), lot number n166150 were provided.The review of the device manufacturing quality record indicates that (b)(4) products optipac monomer pouch 15ml, reference (b)(4), lot number n166150 were manufactured on 27 december 2017.The device manufacturing quality record indicates that the semi-finishedproduct 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.The complaint review could not be performed as the item and lot number of the product were not communicated.With the available information, the exact root cause of the event could not be determined.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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