STRYKER GMBH HEXAPOD STRUT, MEDIUM HOFFMANN LRF 131MM-191MM; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
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Catalog Number 49350030 |
Device Problems
Break (1069); Component Falling (1105)
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Patient Problem
No Code Available (3191)
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Event Date 06/07/2018 |
Event Type
Injury
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Manufacturer Narrative
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Once the investigation has been completed any additional information will be reported in a supplemental report.
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Event Description
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Upon a follow-up visit, 3 of 6 hexapod struts were found to have failed.The pins that hold the strut at the hinge were broken.All 6 struts were pulled and replaced.Rep indicated that the pins weren¿t broken.They fell out.They fell completely out of one strut, and halfway out of the other two.
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Event Description
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Upon a follow-up visit, 3 of 6 hexapod struts were found to have failed.The pins that hold the strut at the hinge were broken.All 6 struts were pulled and replaced.Rep indicated that the pins weren¿t broken.They fell out.They fell completely out of one strut, and halfway out of the other two.
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Manufacturer Narrative
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The reported event that hexapod strut, medium hoffmann lrf 131mm-191mm was alleged of 'implant breakage after surgery' could be confirmed.Based on investigation, the root cause was attributed to be manufacturing and supplier related.The failure was caused by manufacturing components out of specifications.The event involved a product problem indicating a non-conformity which is investigated and addressed through a nc and a capa.No further action is required at this time.Product surveillance will continue to monitor complaints of this type for adverse trends.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If any further information is provided, the investigation report will be updated.
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