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 11/24/2021 |
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 3012447612-2021-00472.
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Event Description
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It was reported four sequoia closure tops stripped during final tightening in surgery.There were no patient impacts.This is report one of four for this event.
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Event Description
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It was reported four sequoia closure tops stripped during final tightening in surgery.There were no patient impacts.This is report one of four for this event.
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Manufacturer Narrative
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Device evaluation: visual inspection revealed that the screw drives of each closure top are slightly stripped.There was no visible damage to the threads.Potential cause root cause was unable to be determined.This event could possibly be attributed to off-axis forces applied during closure top insertion, cross-threading, or using a stripped driver.Dhr review per dhr reviews, the parts were likely conforming when they left zimvie control.Device use this device is used for treatment.If additional information is obtained that adds value to the relevant content of this report, a follow-up report will be sent.
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Search Alerts/Recalls
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