Model Number N/A |
Device Problems
Leak/Splash (1354); Unsealed Device Packaging (1444)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 10/17/2017 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).(b)(6).The product within this report is a combination product.Customer has indicated that the product will not be returned to zimmer biomet for investigation as it was discarded.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
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Event Description
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After opening the boxes it has been noticed that the inner sterile sachet was not completely sealed all the powder was pouring out, it was not possible to use the product.The surgery was completed with another batch causing a delay of 15 minutes.No further information has been made available at this time.
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Manufacturer Narrative
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This following report is being submitted to relay additional information.The following sections have been updated.Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.Review of the complaint history determined the event is likely related to a supplier packaging issue.Corrective action has been initiated to address reported issue.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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