(b)(4).Report source, foreign - event occurred in (b)(6).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.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: g4, e1, h2, h4, h6, h10.The attached photo confirms the reported event.The product analysis can't be performed as the product was not returned.The review of the device manufacturing quality record indicate that 5912 products designation refobacin bone cement r 40x1, reference (b)(4), batch a701ba2601 were manufactured on (16th oct 2017).The device manufacturing quality record (of6154334) 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 complaint issue (complaint category inner cement pouch open sealing) event described in the complaint.16 complaints have been reported over the batch number a701ba2601.According to the available data, the most probable root cause is due to packaging issue (sealing process).Corrective action has been initiated to address reported issue.A customer letter will be sent to the complainant in order to explain the issue.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.
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