Model Number N/A |
Device Problem
Tear, Rip or Hole in Device Packaging (2385)
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Patient Problem
No Patient Involvement (2645)
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Event Date 12/17/2019 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Foreign country: (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: 0001825034-2020-00154.0001825034-2020-00155.0001825034-2020-00156.
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Event Description
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It was reported the warehouse investigated and circulated items and identified inner pouches damaged.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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Upon reassessment of the reported event, the device was determined to be not reportable as there was no breach in sterility.The initial report was forwarded in error and should be voided.
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Event Description
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Upon reassessment of the reported event, the device was determined to be not reportable as there was no breach in sterility.The initial report was forwarded in error and should be voided.
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Search Alerts/Recalls
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