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Catalog Number LONG-G1_AO |
Device Problems
Component Falling (1105); Component Missing (2306)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 08/27/2016 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).This device was returned for service, however did not meet manufacturing specifications during pre-repair assessment.Reliability engineering evaluated the device and observed that the device was missing components as they had fallen out.Therefore, the reported condition was confirmed.The assignable root cause was determined to be due to the degradation of the loctite threadlocker from normal use and servicing over time.If additional information should become available, a supplemental medwatch report will be submitted accordingly.
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Event Description
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It was reported that during service and repair pre-testing, it was observed that the attachment device had missing components.During in-house engineering evaluation, it was determined that the components on the device had fallen out (came apart).The event was not related to 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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