Model Number N/A |
Device Problem
No Flow (2991)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 11/27/2017 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Report source: foreign.The event occurred in (b)(6).The product within this report is a combination product.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Not returned to manufacturer.
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Event Description
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It was reported the monomer liquid could not enter the cartridge.No further information has been made available at this time.
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Manufacturer Narrative
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(b)(4).This follow-up report is being submitted to relay additional information.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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Manufacturer Narrative
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(b)(4).This follow-up report is being submitted to relay additional information.Device history record (dhr) was reviewed and no discrepancies were found.Complaint sample was evaluated and the reported event was confirmed.This analysis concluded that cannulas of the low cylinder were obstructed by powder.This was most likely due to an incorrect use of the product.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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Please refer to report 3006946279-2017-00297.
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Search Alerts/Recalls
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