DEPUY SYNTHES PRODUCTS LLC 11.0 CM LONG ATTACHMENT; MOTOR, DRILL, ELECTRIC - ATTACHMENT
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Catalog Number LONG |
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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(b)(6).This device was returned for service; however, did not meet manufacturing specifications during pre-repair assessment.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 nose cone, bearings and extension sleeve of the attachment device were damaged.It was further determined that the balls and cage were missing.It was observed that the ball bearing had fallen apart.It was further determined that the device failed pretest for lock operation and cutter insertion.It was noted in the service order that the bearing was failing.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 be 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.Reliability engineering evaluated the device and the reported condition was confirmed.A visual and functional assessment was performed on the device which found that the device failed the cutter insertion and some of the red color ring was missing.During service/repair, it was determined that the cutter could not be inserted due to a broken and corroded bearing.The assignable root cause was determined to be due to normal wear out from use.If information is obtained that was not available, a follow-up medwatch will be filed as appropriate.
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Search Alerts/Recalls
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