DEPUY SYNTHES POWER TOOLS MINIMAL ACCESS ATTACHMENT; DRILLS, BURRS, TREPHINES & ACCESSORIES - ATTACHMENT
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Catalog Number MA-D20 |
Device Problem
Positioning Problem (3009)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 01/19/2015 |
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 discovered that the attachment device had no rotation.The event was not related to surgery.There was no patient involvement.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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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 would not rotate.Therefore, the reported condition was confirmed.It was determined that the bearings were worn out.The assignable root cause was determined to be due to normal wear over time.If information is obtained that was not available, a follow-up medwatch will be filed as appropriate.
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