Model Number N/A |
Device Problem
Packaging Problem (3007)
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Patient Problem
No Patient Involvement (2645)
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Event Date 12/07/2018 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Report source: (b)(6).Udi#: (b)(4).Complaint sample was evaluated and the reported event was confirmed.Inspection of the returned device revealed that the reported device has a defective seal.Device history record was reviewed and no discrepancies were found.The root cause of the event is attributed to the design of the device.Corrective / preventive actions related to the reported event have been previously addressed.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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It was reported that during incoming inspection, the seal on the sterile package was found weak.There was no patient involvement.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional and/or corrected information.H4 - manufacturing date is oct 1, 2015 and not oct 1, 2019.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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Event Description
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No further event information available at the time of this report.
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Search Alerts/Recalls
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