Catalog Number 50-1010 |
Device Problem
Device Contaminated During Manufacture or Shipping (2969)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/14/2023 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2023-00158.0001032347-2023-00160.D10: item# 50-1010; lot# 133340.Item# 50-1010; lot# 665630.G2: foreign - event occurred in japan.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product was discarded.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.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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It was reported that during inspection at the receiving warehouse, there was debris found in the sterile packaging.No customer or patient was involved.Attempts have been made and no further information has been provided.
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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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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.No product was returned.A visual inspection was conducted on the customer provided pictures.The photos show debris inside of the sterile packaging.Reported event did not occur in an operating room or as part of a medical procedure; medical records are not available for review.Review of the device history records identified no deviations or anomalies during manufacturing.The likely condition of the device when it left zimmer biomet is non-conforming to specification.The root cause of the reported event is the operator not following the provided work instructions during manufacturing.If any further information 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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