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 10/11/2022 |
Event Type
malfunction
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Event Description
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It was reported that two sequoia closure tops stripped when the surgeon torqued them.Another closure top was used to complete the surgery and there was no reported patient harm; however, there was a 30 minute delay to the surgery.This is report two of two 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 report 3012447612-2022-00250.
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Manufacturer Narrative
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Corrections in d4: lot & udi numbers, d9, h3, and h4.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 sequoia closure tops stripped when the surgeon torqued them.Another closure top was used to complete the surgery and there was no reported patient harm; however, there was a 30 minute delay to the surgery.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 the threads or the hex drives.Root cause: root cause was unable to be determined as no product issue was identified.Dhr review: per dhr review, the part was likely conforming when it left zimvie control.Device usage: 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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Event Description
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It was reported that two sequoia closure tops stripped when the surgeon torqued them.Another closure top was used to complete the surgery and there was no reported patient harm; however, there was a 30 minute delay to the surgery.This is report two of two for this event.
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Search Alerts/Recalls
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