While no serious injury resulted in this event, there has been a previous report received where the cap separation resulted in a serious injury.As a loose cap can lead to cap separation, 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.Evaluated handpiece.Handpiece cap was still attached to head but was loose.Threads where showing and they looked cleaned.No signs of loctite.Also bur insert had some bur wobble/hang up.
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