As a result of this malfunction, the potential for surgical intervention exists to preclude permanent damage to a body structure or permanent impairment of a body function as evidenced by previous reported events with similar files.This event, therefore, is reportable per 21cfr part 803.Returned protaper gold shaping file s1 25mm is actually broken at the tip of the active part (torque).No material defect was found during analysis of the rupture pattern.No unused file is available for evaluation.Nothing unusual to report was found during dhr review (batch #1662776).Root causes are not identified.We will track this kind of event and monitor the trend.
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