DEPUY SYNTHES POWER TOOLS 6.1CM ATTACHMENT, BM; BUR, SURGICAL, GENERAL & PLASTIC SURGERY - ATTACHMENT
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Catalog Number B-SILVER_LL |
Device Problem
Overheating of Device (1437)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 10/14/2015 |
Event Type
malfunction
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Manufacturer Narrative
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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 temperature was over specifications and the bearings were worn.Therefore, the reported condition was confirmed.The assignable root cause was determined to be due to normal use 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 was heating up.The event was not related to surgery.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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Search Alerts/Recalls
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