(b)(4).Report source, foreign - event occurred in (b)(6).The investigation is in progress.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.
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(b)(4).Two product pictures have been received.The first picture received shows the product label with the product reference and batch.The second picture shows the inner cement pouch with a corner of the sealing opened.The product was returned and lab analysis was performed.The product analysis shows that the return product is one cement pack which comprises the outer box, the inner cement pouch, the monomer pouch and the patient labels.The inner pouch sealing is opened at both top and bottom of the pouch, allowing the cement to leak out.Therefore, the reported event is confirmed.The device manufacturing quality record indicate that the released product met all requirements to perform as intended.A sealing force test has been performed on a product received from a similar complaint ((b)(4) - same item reference) and showed that the pouch sealing force a was compliant with zimmer biomet valence specification.A complaint extract was done regarding inner cement pouch open sealing: 21 complaints (21 products), this one included, have been recorded on the brand cement pack soft pouch, all references included, to date (january 07, 2022) 14 complaints (14 products), this one included, have been recorded on biomet bone cement r 1x40 -3, reference 110035372, batch z34eaf1509.According to available data, root cause of the event was unable to be determined.However, a scar ((b)(6)) has been initiated in order to deeper investigate the cause of the event with the cement pouch supplier osartis and to consider to implement actions to avoid the recurrence of this type of 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.
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