Catalog Number UNK_SHC |
Device Problem
Bent (1059)
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Patient Problem
No Patient Involvement (2645)
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Event Date 03/03/2016 |
Event Type
malfunction
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Manufacturer Narrative
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Awaiting device evaluation.A follow up report will be filed once the quality investigation is complete.
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Event Description
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It was reported that during service conducted at the manufacturer a broken bur was found inside the attachment.It was also reported that this event did not occur during a surgical procedure and there was no delay or adverse consequences as a result of this event.
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Manufacturer Narrative
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The device was bent not broken.Investigation results indicate that the router bent as a result of the associated duraguard bending.The bending of the durguard and the router may occur when excessive side load is applied to the devices.
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Event Description
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It was reported that during service conducted at the manufacturer a bent router was found with the associated duraguard.It was also reported that this event did not occur during a surgical procedure and there was no delay or adverse consequences as a result of this event.
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Search Alerts/Recalls
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