Catalog Number 1020-1860 |
Device Problem
Difficult to Remove (1528)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 11/27/2014 |
Event Type
malfunction
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Event Description
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It was reported that when the modular offset quick connect inserter was removed from the stem, after the accolade stem was implanted with this inserter, it was difficult to be removed from the stem.
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Manufacturer Narrative
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A supplemental report will be submitted upon completion of the investigation.
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Manufacturer Narrative
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Device history review: review of the device history records indicate devices were manufactured and accepted into final stock.Complaint history review: there have been no other events reported for the reported manufacturing lot.Visual: the device showed signs of minimal use.There was some minor deformation on the edge of the protrusion that mates with the stem and aligns it to the handle.Dimensional: the critical dimensions required for fit of the inserter into the stem were dimensionally inspected with caliper (b)(4).The device was found to be within specification.Functional: the device was assembled and disassembled onto an accolade ii stem.There was no adverse force required and therefore the event is not confirmed.The event could not be confirmed.The device was found to be fully functional and dimensionally correct.There is no indication at this time that the design, materials, or manufacturing of the subject device contributed to the event.If additional information becomes available, this investigation will be reopened.
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Event Description
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It was reported that when the modular offset quick connect inserter was removed from the stem, after the accolade stem was implanted with this inserter, it was difficult to be removed from the stem.
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Search Alerts/Recalls
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