Model Number N/A |
Device Problem
Unsealed Device Packaging (1444)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 09/10/2017 |
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 inner sterile packaging was compromised and allowed the contents to leak out.This was identified during use.No delay to surgery or additional patient consequences were reported.No further information has been made available at this time.
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Manufacturer Narrative
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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.A summary of the investigation has been sent to the complainant.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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