Model Number N/A |
Device Problems
Infusion or Flow Problem (2964); No Flow (2991)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Information (3190)
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Event Date 12/13/2017 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Multiple mdr's were submitted for this event.Please see reports: 3006946279 - 2018 - 00007.Report source- foreign.The event occurred in (b)(6).Pma 510(k): - 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 of two batches of cement would not enter the cannister.A 15 minute delay to surgery was reported as a result.The surgery was completed with another batch.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. 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.The returned device was evaluated and the device cannula was blocked by a plug of cement, which prevented the monomer to flow inside the device cylinder.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.
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Event Description
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It was been reported that the monomer liquid of the optipac from two different batches would not enter the optipac cylinder.A 15 minute delay to surgery was reported as a result.The surgery was completed with a product from another batch.
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Search Alerts/Recalls
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