In this event it was reported that a contra angle won't hold files; no injury resulted.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.After inspection, replaced cartridge, head cap and hand piece.
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