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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 08/13/2020 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Report source: (b)(6).Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2020-03264, 0001825034-2020-03265, 0001825034-2020-03266, 0001825034-2020-03267, 0001825034-2020-03268.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 there was debris in the sterile packaging.No adverse events have been reported as a result of the malfunction 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.The following sections were updated/corrected updated: b4, b5, d4, d10, g4, h2, h3, h4, h6 complaint sample was evaluated and the reported event was confirmed.Evaluation of the returned product/photographs provided confirmed the following: foreign debris is present inside the sterile packaging.The sterile packaging remains sealed on all devices.The sterility of all devices have been breached.Device history record (dhr) was reviewed and no discrepancies were found.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 work instructions provided.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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No further event information available at the time of this report.
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Search Alerts/Recalls
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