Catalog Number 046W0AN00002 |
Device Problems
Material Deformation (2976); Naturally Worn (2988)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 06/22/2020 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(6).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 3003853072-2020-00060.
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Event Description
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It was reported that during the procedure the threads of two closure tops were damaged.They were removed but no further surgical information was provided.There was no reported patient harm.This is report one of two for this event.
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Manufacturer Narrative
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(b)(4).The complaint is confirmed the reported failure of wear.Visual inspection revealed that the plug was worn on both the head and threads.The damage to the threads of the plugs and the screw tulip head are consistent with cross-threading of the plugs into the screw tulip head during attempted installation.However, a definitive root cause could not be determined.Per dhr review, the part was likely conforming when it left zimmer biomet control.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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Event Description
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No further event information available at the time of this report.
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Search Alerts/Recalls
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