Model Number N/A |
Device Problem
Device Contaminated During Manufacture or Shipping (2969)
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Patient Problem
No Patient Involvement (2645)
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Event Date 01/04/2021 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Report source: (b)(6).Product is in process of being returned to zimmer biomet for the investigation and a follow-up mdr will be submitted upon completion.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2021-00209.
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Event Description
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It was reported that during incoming inspection, debris was found in the sterile packaging.There was no patient involvement.Attempts have been made and additional information on the reported event is unavailable at this time.
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Event Description
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No additional event information to report at this time.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: d9; g3; h2; h3; h4; h6 complaint sample was returned and evaluated against the reported event.Visual evaluation of the returned products identified that there is debris inside the sterile package.The sterility has been compromised.Dhr was reviewed and no discrepancies were found.The likely condition of the products when they left zimmer biomet is non-conforming.The root cause can be attributed to the operator not following instructions during manufacturing.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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Search Alerts/Recalls
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