DEPUY SYNTHES POWER TOOLS MINIMAL ACCESS ATTACHMENT; DRILLS, BURRS, TREPHINES AND ACCESSORIES (SIMPLE, POWERED)
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Catalog Number MA-D20 |
Device Problem
Difficult To Position (1467)
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Patient Problem
No Patient Involvement (2645)
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Event Date 02/06/2015 |
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 was heating in excess.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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Manufacturer Narrative
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The actual device has been returned and is currently pending evaluation.Once reliability engineering evaluates the device, a supplemental medwatch report will be sent accordingly.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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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 the reported condition was confirmed.An assessment was performed on the device which found that there was excess heat due to excessive corrosion on the internal components which was indicative of not following emersion / sterilization procedures.The assignable root cause was determined to be due to component damage caused by misuse, abuse and/ or user error.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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