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.The device is available for evaluation, though results are not available as of this report.Evaluation results will be submitted as they become available.
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Three reciproc files r25 8/100 25mm 025 were returned (one file in loose + two unused files).The file in loose is actually broken at the tip of the active part (fatigue).No material defect was found during analysis of the rupture pattern.For information, the second file which would have broken during use was not returned and cannot be analyzed.The batch number is unknown, dhr cannot be reviewed.Unused files have been evaluated and were found in compliance with specifications.Root causes are not identified.We will track this kind of event and monitor the trend.
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