The reason for this complaint was to report, "the outer packaging is tearing and contaminating the sterile pack".This event caused a 2 minute delay in surgery, the agent was not present.There was no adverse event reported and there was another suitable unit available.The items have not been returned for investigational review.Manufacture of cobalt bone cement was recently transitioned from zimmer biomet to osartis.Shipments were received from osartis beginning (b)(6)2018.Product was shipped to djo customers and consignment locations beginning (b)(4)2018.Three customer complaints have been received in september 2018 reporting problems with the new packaging.The outer pouch of the powder is designed to tear open at the top.When the customer tears the package, they may tear the inner sterile pouch resulting in a loss of the sterility of the cement copolymer powder.A review of the device history record (dhr) revealed no discrepancies or issues with the manufacturing history of this part.All parts conformed to design and manufacturing specifications at the time of manufacture.No non-conforming material reports were associated with this part.Due to multiple complaints being received in a short amount of time and the possibility of increased patient risk, health hazard evaluation (hhe) (b)(4) will be performed to assess patient risk related to this issue.Corrective and preventive action (capa) (b)(4) has been opened to investigate root cause and determine corrective action.
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