Catalog Number C022020000200 |
Device Problems
Break (1069); Material Separation (1562)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Type
malfunction
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Manufacturer Narrative
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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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Event Description
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In this event it was reported that a penetration drill separated in the canal of a patient; the separated piece was retrieved without injury.
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Manufacturer Narrative
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The returned drill is actually broken in the active part.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.This kind of event is tracked and we monitor the trend.
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Search Alerts/Recalls
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