Model Number N/A |
Device Problem
Packaging Problem (3007)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/16/2021 |
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.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2021-02537, 0001825034 -2021 -02538.
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Event Description
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It was reported that upon incoming inspection there was debris found in the sterile package.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. visual evaluation of the returned products identified that there is debris inside the sterile packaging.The complaint has been confirmed by visual evaluation.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.The reported event did not occur in an operating room or as part of a medical procedure; medical records are not available for review.These products left zimmer biomet control non-conforming.The root cause of the reported event 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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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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