Catalog Number 137M0003 |
Device Problems
Difficult to Remove (1528); Physical Resistance/Sticking (4012)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 10/16/2019 |
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 3012447612-2019-00439.
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Event Description
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It was reported that during the procedure the surgeon had difficulty removing the inserter from the implant and a part of it broke off.The inserter was removed by twisting the inner shaft with pliers until it released.No patient harm or significant surgical delay was reported.This is report one of two.
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Manufacturer Narrative
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(b)(4).This follow-up report is being submitted to relay additional information.The complaint is confirmed based on the provided photograph for one returned zyston inner shaft standard inserter or the failure of binding or jammed.Medical records were not provided for review.Per dhr review, the part was likely conforming when it left zimmer biomet control.No actions required.This event is not related to any current actions or recalls or product holds.Root cause was unable to be determined.This event could possibly be attributed to wear through use over time or multiple sterilization cycles.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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