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Catalog Number 05.002.103 |
Device Problems
Dull, Blunt (2407); Separation Problem (4043)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/29/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Device was used for treatment, not diagnosis.If information is obtained that was not available for this medwatch, a supplemental medwatch report will be filed as appropriate.Concomitant med products and therapy dates: attachment device (b)(6) 2021 the actual device was returned for evaluation.Quality engineering evaluated the saw blade device and the reported condition that the saw blade was jammed in the attachment device and could not be removed was not confirmed.Therefore, an assignable root cause was not determined.During evaluation it was determined that the cutting tool could be removed from the dedicated attachment.It was observed that the saw blade showed heavy signs of usage, also a lateral ridge could be verified, which indicated a higher impact, which tightened the saw blade clamping mechanism more than it is possible to do by hand.It was further observed that the cutting tool showed several deformed teeth.The assignable root cause of this condition was determined to be traced to component failure due to wear.A review of the device history was performed and no non-conformances were detected related to the reported condition.Udi ¿ (b)(4).
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Event Description
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It was reported from australia that the sagittal saw attachment had a saw blade jammed and could not be removed.During in-house engineering evaluation it was determined that the cutting tool showed several deformed teeth.This event did not occur during surgery.There was no patient involvement.There were no reports of injuries, medical intervention, or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.
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Search Alerts/Recalls
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