There has been a previous report received with a similar device where this malfunction resulted in a serious injury.Therefore, it must be presumed that recurrence of this malfunction could possibly cause, or contribute to a serious injury or require medical or surgical intervention to preclude such.As such, this event is reportable per 21cfr part 803.Involved start-x tips ems inserst 3 that broke were not returned and cannot be analyzed.Moreover, no unused instrument is available for evaluation.Nothing unusual to report was found during dhr review (batch #: 1626576).No information was given regarding technique, we cannot rule on its compliance with maillefer's recommendations.Root causes are not identified.We will track this kind of event and monitor the trend.Note: the covid-19 pandemic caused a disruption in normal business activities, resulting in late submission of this report.
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