Catalog Number 2155-1 |
Device Problem
Fracture (1260)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/02/2022 |
Event Type
malfunction
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Event Description
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It was reported that during a revision surgery to extend the construct, two incompass drivers fractured when trying to remove the previously-installed closure tops.There were no patient impacts.This is report two of two for this event.
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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 report 3012447612-2022-00197.
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Event Description
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It was reported that during a revision surgery to extend the construct, two incompass drivers fractured when trying to remove the previously-installed closure tops.There were no patient impacts.This is report two of two for this event.
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Manufacturer Narrative
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Additional information in h6: component, investigation type, findings, and conclusions.Device evaluation: the returned devices match the information in the complaint file and were examined.Visual inspection revealed a prong has fractured off the tip of both devices.Root cause: a definitive root cause cannot be determined with the information provided.This event could possibly be attributed to wear through use over time or multiple sterilization cycles.This event could also be attributed to off-axis forces applied during use.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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Search Alerts/Recalls
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