There has been a previous report received 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.Because the guide design was too fragile we redesigned the case according to our design parameters which causes the longer flanges to improve the guide strength.Based on the guide we received for complaint investigation we can conclude the clinician adjusted the flanges in order to have shorter flanges.Unfortunately we did not have any other option than making the flanges longer to avoid breakage of the guide.
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