Catalog Number 0580-1-372 |
Device Problem
Bent (1059)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 09/15/2017 |
Event Type
malfunction
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Manufacturer Narrative
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It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Not available.
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Event Description
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It has been reported that the yellow plastic clip was bent and therefore the stem could not be loaded onto the introducer.
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Manufacturer Narrative
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Additional information: expiration date; manufacturing date; an event regarding damage involving an exeter stem was reported.The event was not confirmed.Method & results: product evaluation and results: not performed as no items were reviewed.Medical records received and evaluation: no medical records were received for review with a clinical consultant.Product history review: all devices were manufactured and accepted into final stock with no relevant reported discrepancies complaint history review: there have been no other similar events for the reported lot.Conclusions: the exact cause of the event could not be determined because further information such as pre- and post-operative x-rays and the primary operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time as no devices and insufficient information were received by stryker orthopaedics.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.
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Event Description
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It has been reported that the yellow plastic clip was bent and therefore the stem could not be loaded onto the introducer.
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Search Alerts/Recalls
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