Model Number N/A |
Device Problem
Clumping in Device or Device Ingredient (1095)
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Patient Problem
No Patient Involvement (2645)
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Event Date 11/08/2018 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Report source (b)(6).This product is not cleared for distribution in the u.S.However, this report is being submitted as a similar device is cleared for distribution under 510k number k150850.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
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Event Description
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It was reported that during a surgery, the polymer was found to be hardened upon opening the bag of bone cement, a different product was needed to complete the surgery.No adverse events were reported as a result of this malfunction.Attempts have been made and additional information on the reported event is unavailable at this time.
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Manufacturer Narrative
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Udi# (b)(4).Complaint sample was evaluated and the reported event was confirmed.Visual inspection of the returned product identified that some amount of the cement powder had hardened on the tyvek side of the pouch.There was a slight brown discoloration on the rear side of the tyvek around the hardened cement.There was no puncture or damage to the packaging.Dhr was reviewed and no discrepancies were found.Root cause was unable to be determined.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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No additional event information to report at this time.
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Search Alerts/Recalls
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