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 12/15/2021 |
Event Type
malfunction
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Event Description
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It was reported that two closure tops stripped during final tightening intra-operatively.They were removed and replaced with other closure tops to completed the procedure without patient impacts.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 3012447612-2022-00002.
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Manufacturer Narrative
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Device evaluation: visual inspection revealed minor damage to the threads and screw drives of the closure tops.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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Event Description
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It was reported that two closure tops stripped during final tightening intra-operatively.They were removed and replaced with other closure tops to completed 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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