This follow-up report is being submitted to relay additional information.The complaint has been confirmed through visual inspection of the returned product.Visual inspection of all the products returned for investigation identified loose foam debris within the sealed sterile packaging.Device history record was reviewed and no discrepancies were found.The root cause of the reported issue is attributed to transit damage.This device falls within the scope of a corrective action which is to assess all current sterile barrier systems used to package products at zimmer biomet bridged.As part of this corrective action, 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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