Catalog Number 4712500398-3 |
Device Problem
Infusion or Flow Problem (2964)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 04/10/2018 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The device was not returned to the manufacturer.Therefore it could not be analyzed.The device manufacturing quality record indicates that the released product met all requirements to perform as intended.Investigation results concluded that the product is conform and the root cause is undetermined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly zimmer biomet will continue to monitor for trends.
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Event Description
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It has been reported that the monomer fluid wasn't injected into the cartridge after having pressed the blue brackets.
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Event Description
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It has been reported that the monomer fluid wasn't injected into the cartridge after having pressed the blue brackets.
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Manufacturer Narrative
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(b)(4).This follow-up report is being submitted to relay additional information.The device manufacturing quality record indicates that the released product met all requirements to perform as intended.Complaint sample was evaluated and the reported event was confirmed.No product non-conformity was identified.Product analysis showed that the most probable root cause is a handling error.Investigation results concluded that the reported event was likely due to an handling error.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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Search Alerts/Recalls
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