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 02/16/2022 |
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 3012447612-2022-00059.
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Event Description
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It was reported that two closure tops stripped during final tightening intraoperatively.They were removed and replaced with new closure tops to complete the procedure without patient impacts.This is report two of two for this event.
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Manufacturer Narrative
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Device evaluation: visual inspection revealed no damage to either the threads or drives.There is minor cosmetic damage to the tops of the devices.The damage seen is commensurate with what is expected from use.The complaint is not confirmed for a product issue.Potential cause: root cause was unable to be determined as no product issue was found.Dhr review: per dhr review, the parts were likely conforming when they left zimvie control.Device use: these devices are 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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Event Description
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It was reported that two closure tops stripped during final tightening intraoperatively.They were removed and replaced with new closure tops to complete the procedure without patient impacts.This is report two of two for this event.
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Search Alerts/Recalls
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