Catalog Number 6541-2-700 |
Device Problems
Break (1069); Sticking (1597); Material Integrity Problem (2978); Scratched Material (3020)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
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Event Date 03/12/2015 |
Event Type
malfunction
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Event Description
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Reused fluted headless pin became stuck on tibial cutting block and staff, then broke pin inside triathlon pin driver.
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Manufacturer Narrative
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When completed, the investigation results will be submitted in a supplemental report.
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Manufacturer Narrative
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An event regarding seizing of a fluted headless pin within a tibial resection guide was reported.The event was not confirmed.Method & results: device evaluation and results: a functional analysis could not confirm the event.A headless pin was able to pass through all 10 holes with no resistance.Medical records received and evaluation: not performed as patient factors did not contribute to the event.Device history review: all devices accepted into final stock conformed to specification.Complaint history review: there have been no similar previous reported events for this lot id.Conclusions: the reported event could not be replicated.No product problem was found with the device.The pin associated with this event was not returned for investigation.No further investigation is required at this time.
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Event Description
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Reused fluted headless pin became stuck on tibial cutting block and staff then broke pin inside triathlon pin driver.
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Search Alerts/Recalls
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