Catalog Number 046W0AN00002 |
Device Problem
Fracture (1260)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 11/08/2016 |
Event Type
malfunction
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Manufacturer Narrative
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Without a product return, no product evaluation is able to be conducted.Current information is insufficient to permit a valid conclusion about the cause of this event.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.Reference report 3003853072-2016-00164.
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Event Description
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It was reported that during final tightening, the threads of two blockers were damaged.They were removed and replaced with alternative blockers.There was a short surgical delay, but there were no reports of patient injury.This is report two of two for this event.
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Manufacturer Narrative
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The product was not returned, however a photograph of the device was provided.The photograph showed the blocker was damaged on the threads.A review of the manufacturing records did not identify any issues which would have contributed to this event.The labeling was reviewed and found to contain instructions regarding proper device usage.
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Search Alerts/Recalls
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