Catalog Number C010120000100 |
Device Problems
Break (1069); Material Separation (1562)
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Patient Problems
No Known Impact Or Consequence To Patient (2692); Insufficient Information (4580)
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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 rs penetration drill separated during use.The outcome of the event is unknown as of this mdr evaluation.
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Manufacturer Narrative
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Involved rs penetration drill 1 that broke during use was not returned, no analysis of the fragments can be made.Nothing unusual to report was found during dhr review (batch #1563126).For information, product design and manufacturing process are unchanged since 2007.Root causes are not identified.We will track this kind of event and monitor the trend.
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Search Alerts/Recalls
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