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Model Number N/A |
Device Problem
Device Contaminated During Manufacture or Shipping (2969)
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Patient Problem
No Information (3190)
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Event Date 07/22/2020 |
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 - 03132, 0001825034 - 2020 - 03133, 0001825034 - 2020 - 03134, 0001825034 - 2020 - 03135, 0001825034 - 2020 - 03136.
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Event Description
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It was reported circulated items were investigated and identified debris in sterile package.No patients were involved.No additional information.
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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: b4, b5, d4, d10, g4, h2, h3, h4, h6 upon receipt of additional information, it has been determined that this device did not contain any debris that would compromise sterility.The initial report was forwarded in error and should be voided.Complaint sample was evaluated and the reported event was confirmed.Evaluation of the returned product/photographs provided confirmed there is debris inside the sterile packaging which is consistent with the appearance of foam debris from the foam packaging inside the sterile barrier.Sterility has not been compromised.Device history record (dhr) was reviewed and no discrepancies were found.The likely condition of the product when it left zimmer biomet was conforming to specification.The root cause of the reported event is likely to be due to transit damage.A corrective action has been initiated to address this issue.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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Upon receipt of additional information, it has been determined that this device did not contain any debris that would compromise sterility.The initial report was forwarded in error and should be voided.
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Search Alerts/Recalls
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