DEPUY SYNTHES PRODUCTS LLC 5.0 CM SHORT ATTACHMENT; MOTOR, DRILL, ELECTRIC - ATTACHMENT
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Catalog Number SHORT |
Device Problem
Detachment Of Device Component (1104)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 01/01/2018 |
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.A visual and functional assessment was performed on the device which found that the device passed all tests.The device is being returned for further investigation.Once the investigation has been completed, a supplemental medwatch will be submitted.If additional information should become available, a supplemental medwatch will be submitted accordingly.
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Event Description
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It was reported by (b)(6) that during service and evaluation, it was determined that the bearings of the attachment device were damaged.It was further determined that the device identification was unreadable.It was further determined that the ball bearings had fallen apart and the triangle symbol, color ring , balls and cage were missing.It was observed that the device failed lock operation and cutter insertion.It was noted in the service order that the burr devices slipped out of the device.This event did not occur during surgery.There was no patient involvement.There were no reports of injuries, medical intervention or prolonged hospitalization.The exact date of the event was unknown.However, it was reported that the event occurred in 2018.All available information has been disclosed.If additional information should available, a supplemental medwatch will be submitted accordingly.
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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.During repair, it was determined that the reported condition was not confirmed.A visual and functional assessment was performed and the device passed all operational specifications.Therefore, an assignable root cause was not determined.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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