Catalog Number 14-524216 |
Device Problems
Fracture (1260); Material Deformation (2976)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 06/15/2020 |
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.The lot number is unknown; therefore the device history records are unable to be reviewed.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 3012447612-2020-00337.
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Event Description
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It was reported that during the procedure the threads of the tulip heads of two screws were damaged while the gun reducer was being used.All the material was removed from the patient and the damaged screws were removed and replaced with alternates to complete the case.There was no reported patient harm.This is event one of two for this event.
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Event Description
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No further event information available at the time of this report.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.D6: not implanted.D7: not explanted.D11: catalog#: 14-524216 lineum 3.5mm x 16mm cc screw lot#: ni.The event is confirmed with photographs received.Visual examination of the provided pictures identified the two screws had fractured.Device history record review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was unable to be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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Search Alerts/Recalls
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