While no serious injury resulted in this event, 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.The device is available for evaluation, though results are not available as of this report.Evaluation results will be submitted as they become available.
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Returned start-x tip ems insert 3 is actually broken in the active part.No material defect was found during analysis of the rupture pattern.No unused device is available for evaluation.The batch number is unknown, dhr cannot be reviewed.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.
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