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 10/24/2022 |
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 reports 3012447612-2022-00263 through 3012447612-2022-00267.
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Event Description
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It was reported that five sequoia closure tops stripped while being final tightened intra-operatively.Other closure tops were used to complete the procedure.There was a delay of about 30 minutes, but there were no patient impacts.This is report three of five for this event.
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Manufacturer Narrative
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Device evaluation: visual inspection revealed no clear damage to any of the hex drives.Visual inspection revealed that 3 of the closure tops had damaged threads, but 2 closure tops did not (lot: abg).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 review, the parts were likely conforming when they left zimvie control.Device use this device is used for treatment.A follow-up report will be sent if additional information is obtained that adds value to the relevant content of this report.
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Event Description
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It was reported that five sequoia closure tops stripped while being final tightened intra-operatively.Other closure tops were used to complete the procedure.There was a delay of about 30 minutes, but there were no patient impacts.This is report three of five for this event.
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Search Alerts/Recalls
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