On (b)(6) 2015 integra investigation completed.Manufacture date unknown.Method: failure analysis, device history evaluation.Results: failure analysis - a contra angle was returned in used condition, not showing any unusual markings.Device is showing wear, residue and broken screw top.Upon the evaluation of the angle it is confirmed that the screw has fallen off.It also appears to have built up residue on the screw area.Without knowing how the instrument was maintained and handled, the cause of the complaint report is undetermined.This type of damage is typically the result of improper processing.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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