Catalog Number 07.02030.002 |
Device Problem
Material Deformation (2976)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/28/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Current information is insufficient to permit a valid conclusion about the cause of this event.A follow up report will be sent upon completion of the device evaluation.Reference reports 3012447612-2022-00147 through 3012447612-2022-00149.
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Event Description
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It was reported that three vitality connectors stripped intra-operatively; the screw driver kept turning with all three.They were each removed and replaced with a fourth connector to complete the procedure without patient impacts.This is report three of three for this event.
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Manufacturer Narrative
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Corrections in d4: udi number and h3.Additional information in h4 and h6: component, investigation type, findings, and conclusions.Device evaluation: visual inspection revealed no signs of damage.A functional inspection was performed with a set screw starter (07.02119.001 lot 102938) and found that the two connectors with lot number p141383 have one screw that continuously turns while the other end does tighten as expected.Neither screw on the connector with lot number w724491 tighten.Potential cause: root cause was unable to be determined.This event could possibly be attributed to the screws being turned through getting stuck or cross-threaded.Dhr review: per dhr review, the part was likely conforming when it 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 three vitality connectors stripped intra-operatively; the screw driver kept turning with all three.They were each removed and replaced with a fourth connector to complete the procedure without patient impacts.This is report three of three for this event.
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Search Alerts/Recalls
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