There has been a previous report received where breakage resulted in a serious injury with a similar device.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.The returned easypost precision drill 2 is actually broken at the base of the operating part.No wear off was noted.No material defect was found during analysis of the rupture pattern.The batch number is unknown, dhr cannot be reviewed.Root causes are not identified notably because the circumstances in which the instrument broke remain unclear.As the operating part is slightly curved, the instrument might have broken during an attempt from a user to straighten it.We will track this kind of event and monitor the trend.
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