Catalog Number 2000-9061 |
Device Problem
Fracture (1260)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/31/2023 |
Event Type
malfunction
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Event Description
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It was reported that two polaris plug drivers fractured intra-operatively during the final tightening with no harm to patient or delay to procedure.This is report one 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.
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Manufacturer Narrative
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Additional information in h6: component, investigation type, findings, and conclusions.Inspection: the returned device matches the information in the complaint file and was examined.Visual inspection revealed the tip has fractured off.Dhr review: the dhr was reviewed.There are no indications of manufacturing issues which would have contributed to this event and the device was likely conforming when it left highridge¿s control.Potential 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.Device usage: 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.Reference report 3012447612-2023-00382.
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Event Description
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It was reported that two polaris plug drivers fractured intra-operatively during the final tightening with no harm to patient or delay to procedure.This is report one of two for this event.
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Search Alerts/Recalls
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