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Model Number N/A |
Device Problem
Manufacturing, Packaging or Shipping Problem (2975)
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Patient Problem
No Patient Involvement (2645)
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Event Date 12/18/2019 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Udi #: (b)(4).Report source: (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.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2020-00158, 0001825034-2020-00159.
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Event Description
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It was reported the incoming inspection team member found debris in sterile package, in the warehouse.No patient involvement.Attempts have been made and additional information on the reported event is unavailable at this time.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Reported event was confirmed with product return.Visual evaluation of the returned products identified that there is foreign debris inside the sterile packages.This reported event falls within the scope of a previous capa, the purpose of which is to address the issue of complaints for debris in sterile packaging.A corrective action was opened to assess all current sterile barrier systems used to package products at zimmer biomet bridgend.As part of this action, the pouch is being improved to use a stronger material (nylon), and foam end caps are being added.Also, the orientation the devices are packed in the shipper box is moving from vertical to horizontal, and the thickness of the shipper box has been increased.Review of the device history records identified no related deviations or anomalies.These products likely left zimmer biomet control non-conforming.The root cause of the reported issue (foreign debris) is attributed to manufacturing deficiency.The root cause of the foam debris is attributed to transit damage.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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