Catalog Number 856207006 |
Device Problem
Manufacturing, Packaging or Shipping Problem (2975)
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Patient Problem
No Patient Involvement (2645)
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Event Date 09/13/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Zimmer biomet complaint number - (b)(4).(b)(4).Foreign - (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.Product not returned.
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Event Description
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It was reported that during incoming inspection at the warehouse, it was reported that incoming inspection member at the warehouse found a part of the sterile seal packaging is peeling off.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 information.Updated: complaint sample was evaluated and the reported event was not confirmed.After visual evaluation, the packaging seal was determined to be conforming to the applicable acceptance criteria.Dhr was reviewed and no discrepancies were found.The complaint was not confirmed because the device met specification.As a result of the investigation results, this event would not be considered mdr reportable.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 additional information received.
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Search Alerts/Recalls
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