Catalog Number PTA00010 |
Device Problem
Break (1069)
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Patient Problem
No Code Available (3191)
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Event Date 06/10/2015 |
Event Type
malfunction
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Manufacturer Narrative
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Investigation not complete.Product has not been returned.Trends will be evaluated.This report will be updated when the investigation is complete.
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Event Description
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Allegedly, the knob used to tighten the prophecy foot holder on the sliding rails was stripped and the physician was unable to loosen it, which added 30 minutes to the procedure.
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Manufacturer Narrative
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Visual inspection of the returned parts found that the turning knob is stuck (not turning) in c-bracket moving arm.Other than that there was no other unusual damage observed.Analysis of the returned devices indicates that the device was a contributor to the reported event.Based on analysis, a definitive root cause could not be determined; however the most likely root cause was due to cross threading in the aluminum c-bracket moving arm caused by external stresses applied to the screw.The part was in use almost 4 years and the age is the contributor to the issue.
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Search Alerts/Recalls
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