On 11/08/2016 integra investigation completed.Date of manufacture: 12/2013 and 05/2014.Method: failure analysis, device history evaluation.Results: failure analysis - two forceps returned in used condition, not showing any unusual markings.The returned forceps showing wear, staining/discoloration, cracking and a slightly bent tip.Upon visually inspecting the instruments, it is noticed that the hinge has excessive staining and discoloration.There is also cracking/breakage on one out of the two hinges.One of the tips are slightly bent.The complaint is confirmed.Device history evaluation - dhr review: nonconforming product report / nonconforming material report history: variance authorization / deviation history: there is no applicable variance authorization / deviation history: 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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