2/22/16 integra investigation completed.Method : failure analysis, device evaluation history results : failure analysis - a ferris smith rongeur was returned used, showing no unusual markings and a missing pin.The rivet at the jaw has shorn off.Based on our investigation, we have no indication whatsoever that either the design, material or manufacturing process, or any circumstances within our sphere of influence have given cause for any corrective or preventative action to be initiated by us.Complaint is confirmed; device evaluation history - dhr was based on all history.Nonconforming product report / nonconforming material report history: none.Variance authorization / deviation history: no variance authorization/deviation history reported at this time.Engineering change order/manufacturing change order history: none.Corrective action preventive action history: none.Health hazard evaluation history: none.Conclusion the complaint report is confirmed; root cause undetermined.
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