Model Number 6000-999-004 |
Device Problems
Material Fragmentation (1261); Material Deformation (2976)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 10/21/2019 |
Event Type
malfunction
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Event Description
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It was reported that during set up for a procedure the device was found stripped and broken.The device being fragmented poses a risk of a small component being lost in the surgical site.No medical intervention and no adverse consequences were reported with this event.As this event occurred during setup at the user facility, there was no patient involvement and no delay to a surgical procedure.
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Manufacturer Narrative
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Device evaluation: follow-up report submitted to document device evaluation results.
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Event Description
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It was reported that during set up for a procedure the device was found stripped and broken.The device being fragmented poses a risk of a small component being lost in the surgical site.No medical intervention and no adverse consequences were reported with this event.As this event occurred during setup at the user facility, there was no patient involvement and no delay to a surgical procedure.
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Search Alerts/Recalls
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