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.Involved product broken during use was not returned and cannot be analyzed.Nothing unusual to report was found during dhr review.The five unused k-files colorinox 25mm 008 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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