Model Number N/A |
Device Problem
Device Packaging Compromised (2916)
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Patient Problem
No Information (3190)
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Event Date 05/16/2018 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4) foreign - event occurred in (b)(6).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 the product protruded through sterile packaging.The surgery was completed with another device.
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Manufacturer Narrative
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This follow-up report is being submitted to relay updated and additional information.(b)(4).Complaint sample was evaluated and the reported event was confirmed.Visual inspection confirms the part has broken through the sterile cavity.Dhr was reviewed and no discrepancies relevant to the reported event were found.The likely condition of the product when it left zimmer biomet was conforming to all specifications.It is likely that the reported event occurred during shipping.However, a specific root cause cannot 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 further event information available at the time of this report.
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Search Alerts/Recalls
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