Catalog Number 1013-00-901 |
Device Problem
Material Twisted/Bent (2981)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 10/09/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Device history record review: a device history review was performed and no non-conformances were detected related to the reported condition.Device evaluation: the device was returned for service; however, did not meet manufacturing specifications during pre-repair assessment.Quality engineering evaluated the device and observed that the polymeric cap was dented.It was further determined that denting of the end cap was a normal result and the denting did not affect the function of the cap.It was determined that the damage was caused by normal wear.Therefore, the reported condition was confirmed.The assignable root cause was due to normal wear out from use.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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Event Description
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It was reported that during service and repair pre-testing, it was discovered that the cap for head adapter femoral device failed visual assessment and the polymeric cap was dented.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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Upon further review of the complaint, it was determined that the reported malfunction is unlikely to cause or contribute to serious injury or death if it were to recur.Therefore, this complaint is not reportable.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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Search Alerts/Recalls
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