Model Number NN271K |
Device Problem
Detachment Of Device Component (1104)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 05/03/2017 |
Event Type
malfunction
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Manufacturer Narrative
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Reported device not marketed in the u.S., however, similar devices or devices that share components, raw materials, process methods or any other technological characteristics with a medical device that is registered within the u.S.(b)(4).Manufacturing site evaluation: evaluation on-going.Device not returned.
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Event Description
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(b)(6).It was reported that a revision surgery was required due to a columbus inlay spinout.Components in use listed as concomitant devices are: nn271k / columbus rp tibial plateau cemented t1, nn261k / tibial obturator d12mm, nn910k / columbus cr narrow femur cemented f5nr.
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Manufacturer Narrative
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Investigation: according to the reference photos received, we found that the slot is damaged.Additionally we found visible damge and unknown residues.Batch history review: the device quality and manufacturing history records have been checked for all the lot numbers and found to be according to the specification, valid at the time of production.Conclusion and root cause: the root cause of the problem is most probably patient related.Rational: according to the quality standard and dhr files, a material defect and production error can be excluded.No similar incidents have been filed with products from this batch.We assume the traumatic influences as a causal factor.No capa is necessary.
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Search Alerts/Recalls
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