Catalog Number 3301-1 |
Device Problem
Material Deformation (2976)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/25/2021 |
Event Type
malfunction
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Event Description
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It was reported four sequoia closure tops stripped during final tightening intra-operatively.There were no patient impacts.This is report two of four for this event.
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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 reports 3012447612-2021-00473 through 3012447612-2021-00476.
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Manufacturer Narrative
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Inspection: the returned devices were examined.Visual inspection revealed that the screw drive on each closure top was stripped.Dhr review: the dhr was reviewed.There are no indications of manufacturing issues that would have contributed to this event and the devices were likely conforming when they left zimvie¿s control.Potential root cause: a definitive root cause cannot be determined with the information provided.This event could possibly be attributed to off-axis forces or incomplete insertion of drive mechanism during final torqueing.Device usage: this device is used for treatment.
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Event Description
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It was reported four sequoia closure tops stripped during final tightening intra-operatively.There were no patient impacts.This is report two of four for this event.
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Search Alerts/Recalls
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