Patient initially reports screw comes out of the head of the angles.On (b)(6) 2015 customer reports screws fell out when doctor was working with device on a tray, no patient contact at the time, no further information available.Customer fears screws could have fallen off in patient mouth.
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On 9/4/2015 integra investigation completed.Method: failure analysis, device history evaluation.Manufacture date unknown.Results: failure analysis: there were two contra angles in used condition, not showing any unusual markings.Upon the evaluation of the angle it is confirmed that the screw has fallen off.Without knowing how the instrument was maintained and handled, the cause of the complaint report is undetermined.It is possible the screw fell out due to the vibration to the instrument causing the screws to loosen; eventually falling out.Device history evaluation: dhr review was completed with all history available.Nonconforming product report / nonconforming material report history: there is no applicable nonconforming product report / nonconforming material report history.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: none.Health hazard evaluation history: none.Conclusion: the complaint report has been confirmed; the root cause has not been identified as a workmanship or material deficiency.
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