DEPUY SYNTHES POWER TOOLS 8.2CM ATTACHMENT, BLACK MAX; BUR, SURGICAL, GENERAL & PLASTIC SURGERY - ATTACHMENT
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Catalog Number B-VIOLET |
Device Problem
Overheating of Device (1437)
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Patient Problem
No Patient Involvement (2645)
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Event Date 01/12/2015 |
Event Type
malfunction
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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 high temperature.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 report will be submitted accordingly.
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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 the reported condition was confirmed.The assignable root cause was determined to be due to worn out bearings 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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