Catalog Number 14-440052 |
Device Problem
Shipping Damage or Problem (1570)
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Patient Problem
No Patient Involvement (2645)
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Event Date 01/08/2019 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).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 a puncture on the outer package, penetrating the inner packaging, was found during receiving inspection.There was no patient involvement.
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Manufacturer Narrative
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Udi# (b)(4).The visual inspection of the returned product identified that the outer box and the sterile packaging had a hole punctured through, confirming the reported event.Review of the device history records identified no relevant deviations or anomalies.The root cause of the reported event is attributed to transit damage.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 additional information received.
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Search Alerts/Recalls
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