(b)(4).Report source: (b)(6).Evaluation of the returned confirmed foreign debris is present inside the sterile packaging, and the sterile packaging remains sealed.Further evaluation found damage to sterile blister and debris inside the sterile packaging which is consistent with the appearance of the porous coating.The reported event is confirmed.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.The likely condition of the device when it left zimmer biomet is non-conforming to specification.The root cause of the foreign debris reported event is the operator not following the work instructions provided.The root cause of the white foam and black porous coating debris is likely to be damage during transit.This device falls within the scope of ca-03419 for the black porous coating debris and sterile packaging damage, the purpose of which is to assess all current sterile barrier systems used to package products at zimmer biomet bridgend.As part of this capa, the pouch is being improved to use a stronger material (nylon), and foam end caps are being added.Also, the orientation the devices are packed in the shipper box is moving from vertical to horizontal, and the thickness of the shipper box has been increased.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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