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 12/28/2018 |
Event Type
malfunction
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Manufacturer Narrative
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(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.
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Event Description
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It was reported that debris was found in the sterile packaging during receiving inspection.There was no patient involvement.
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Event Description
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No additional information received.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Visual inspection of the returned product determined that the product packaging is acceptable per applicable criteria; there was no debris in the sterile packaging and the product sterility was not compromised.Given the investigation found no failure and determined the product is within specification, this event is being reassessed as a non fda reportable event as there was no injury or product malfunction.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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Search Alerts/Recalls
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