Visual evaluation of the returned product identified that the perforations on the outer carton have been damaged.The complaint has been confirmed by visual evaluation.Review of the device history records identified no deviations or anomalies during manufacturing.The product was likely conforming when it left zimmer biomet control.The root cause of the reported issue is attributed to transit damage.This device falls within the scope, the purpose of which is to assess all current sterile barrier systems used to package products at zimmer biomet bridgend.The pouch for the device is being improved to use a stronger material (nylon), and foam end caps are being added to prevent friction.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.
|