(b)(4).Products have been returned to biomet spain for evaluation and forwarded to a regulatory compliance engineer for investigation.Summary of investigation: taken into account the following facts: the foam (ref.Jv540125; lot 4907120) and the tyvek (reference jv540073; lot 0000761004) of the returned product have been verified and matches with the ones indicated on the bill of material of the manufacturing order.The lidding material consists of a coated and an uncoated side.The coated lid surface contains glue on all its surface, this coated side is the part to contact the blister surface.According to the blister specifications, the effective sealing rim is 10mm.The sealing machine is a flat surface which applies heat on all the lid surface.A review of the manufacturing history records confirms no abnormalities or deviations reported.A review of the complaint database has found no similar complaints reported with this item # / lot # combination.A trend has been identified regarding issues with the tyvek lid sticking to the top foam on various implants, which cause the implant to fall out of the blister pack when opened in surgery.As a result of this trend a hhed2015-028 was initiated.It can be seen from the photographs that the impressions left in the foam would likely result in the middle section of the top foam being in contact with the tyvek lid thus causing the adhesion to take place as described within the pce summary.Investigation is completed based on current available information.If any additional information becomes available, then the complaint will be reopened and investigated.
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