On 9/21/16 integra investigation completed.Method: failure analysis, devise history evaluation results: failure analysis - failure analysis cannot be performed based on the lack of information provided by the customer.The rongeurs were not returned for further evaluation.Devise history evaluation - nonconforming product report / nonconforming material report history: none variance authorization / deviation history: none engineering change order/manufacturing change order history: there is no applicable engineering change order/manufacturing change order history.Corrective action preventive action history/corrections: none.Health hazard evaluation history: none.Conclusion: root cause cannot be determined due to the lack of information received to perform a complete investigation.The rongeurs were not returned for further evaluation.
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