Model Number N/A |
Device Problems
Device Packaging Compromised (2916); Manufacturing, Packaging or Shipping Problem (2975)
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Patient Problem
No Patient Involvement (2645)
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Event Date 05/02/2018 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Report source, foreign - the 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 incoming inspection member found debris in the sterile package.Attempts have been made and additional information on the reported event is unavailable.
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Manufacturer Narrative
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(b)(4).Complaint sample was evaluated and the reported event was confirmed.Visual inspection shows that there is foreign debris trapped within the sterile package.Device history record was reviewed and no discrepancies were found.Investigation results concluded that the reported event was due to operator not following instructions during the manufacturing process.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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