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 12/02/2021 |
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 reports 3012447612-2021-00481 through 3012447612-2021-00484.
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Event Description
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It was reported four closure tops stripped during final tightening intra-operatively.There were no patient impacts.This is report three of four for this event.
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Event Description
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It was reported four closure tops stripped during final tightening intra-operatively.There were no patient impacts.This is report three of four for this event.
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Manufacturer Narrative
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Device evaluation visual inspection revealed that the threads were stripped on each closure top.It was also seen that one of the closure tops of ln abb had hex damage.Potential cause.Root cause was unable to be determined.This event could possibly be attributed to wear through use over time or multiple sterilization cycles.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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