DEPUY SYNTHES POWER TOOLS 5 CM SHORT ATTACHMENT, G1; MOTOR, DRILL, ELECTRIC - ATTACHMENT
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Catalog Number SHORT-G1 |
Device Problem
Migration or Expulsion of Device (1395)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 06/22/2016 |
Event Type
malfunction
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Manufacturer Narrative
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The 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 had missing components: bearings, bearings spacers and bearings stack.Therefore, the reported condition was confirmed.The assignable root cause was determined to be due to degradation (wear) of the loctite threadlocker from normal use and servicing over time.If additional information should become available, a supplemental medwatch report will be sent 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 bearing stack came out of the attachment device.The event was not related to surgery.There was no patient involvement reported.There were no injuries or medical intervention associated with this event.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.
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