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 11/20/2023 |
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.
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Event Description
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It was reported, that the tip of a polaris 5.5 plug driver broke, during final tightening intra-operatively.There was no patient impact.And another plug driver was used to complete the procedure.
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Manufacturer Narrative
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Device evaluation: the device was not returned and no photos were provided, so an evaluation is unable to be performed.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.Dhr review: per dhr review, the part was likely conforming when it left highridge 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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Event Description
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It was reported that the tip of a polaris 5.5 plug driver broke during final tightening intra-oepratively.There was no patient impact and another plug driver was used to complete the procedure.
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Search Alerts/Recalls
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