Model Number FF490T |
Device Problems
Material Separation (1562); Separation Problem (4043)
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Patient Problems
No Known Impact Or Consequence To Patient (2692); No Code Available (3191)
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Event Date 12/11/2018 |
Event Type
Injury
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Manufacturer Narrative
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Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.
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Event Description
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It was reported that the device was broken during surgery.Clamp and pin were separated.The device was replaced by a new one and caused a surgery delay of 10 to 15 minutes.There was no patient harm.There was no additional information provided.
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Manufacturer Narrative
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Investigation results: the implant arrived detached with cut off pin.Investigation was carried out microscopically.Here we found, that the pin was cut underneath the latch that has fixed the upper disc.The manufacturing documents have been checked and found to be according to specification valid during the time of production.There is no further complaint with this lot at hand.The root cause for the problem is most probably usage related.The pin was cut off underneath the latch that has fixed the upper disc.The wear on the first latch underneath the cutting edge is a sure hint that the spring segment of the upper disc was not driven completely over the next latch.A capa was not initiated.
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Search Alerts/Recalls
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