Model Number 83-1615 |
Device Problem
Chemical Problem (2893)
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Patient Problem
Insufficient Information (4580)
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Event Date 11/04/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Product complaint # (b)(4).No 510k as device is not marketed in the united states under this product code, but the same/similar product is marketed in the us under a different product code.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Event Description
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Today we mixed a batch of smart set ghv bone cement and the scrub nurse could not push the white pusher into the top of the smartmix cemvac mixing system.When she eventually got it in and mixed the cement it looked lumpy instead of smooth.This was not used and we tried again with a new mix.We had the same isse with the white rod in the top of the mixer but the mix looked better.However when we went to use it stayed running and sticky for a longer time than normal (approx 5 minutes) and was noticed that there were small lumps.The surgeon wasn't happy to continue.We then mixed a third batch of cement from a different supplier (cement and mixing system).15 minute surgical delay.Surgery successfully completed.
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Manufacturer Narrative
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Product complaint # (b)(4).No 510k as device is not marketed in the united states under this product code, but the same/similar product is marketed in the us under a different product code.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Event Description
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Today we mixed a batch of smart set ghv bone cement and the scrub nurse could not push the white pusher into the top of the smartmix cemvac mixing system.When she eventually got it in and mixed the cement it looked lumpy instead of smooth.This was not used and we tried again with a new mix.We had the same isse with the white rod in the top of the mixer but the mix looked better.However when we went to use it stayed running and sticky for a longer time than normal (approx 5 minutes) and was noticed that there were small lumps.The surgeon wasn't happy to continue.We then mixed a third batch of cement from a different supplier (cement and mixing system).15 minute surgical delay.Surgery successfully completed.
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Manufacturer Narrative
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Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot: a manufacturing record evaluation was performed for the finished device lot number, and no non-conformances related to the malfunction were identified.
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Search Alerts/Recalls
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