On 11/08/2016 integra investigation completed.Method: failure analysis, device history evaluation.Results: failure analysis - forceps returned in used condition, not showing any unusual markings, showing wear, discoloration/staining within the finish and a tip is broken.Without knowing how the forcep was handled and maintained, the cause is undetermined.The complaint is confirmed.Device history evaluation - dhr review nonconforming product report / nonconforming material report history: none.Variance authorization / deviation history: none.Engineering change order/manufacturing change order history: none.Corrective action preventive action history: none.Health hazard evaluation history: none.Conclusion: the root cause has not been identified as a workmanship or material deficiency.
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