Catalog Number A000824000100 |
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.The device is available for evaluation, though has not been returned 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 three gates drills separated; no injury resulted.The broken parts have been retrieved.
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Manufacturer Narrative
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The two gates ra 32mm 1 returned in loose are actually broken at the base of the neck portion (expected breakage area).No material defect was found during analysis of the rupture patterns.Unused product has been evaluated according to iso standard and meets expectations.Nothing unusual to report was found during dhr review (batch #1476046).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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