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 10/16/2018 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).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 debris was found in the sterile packaging at the distribution center.No patient involvement.
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Manufacturer Narrative
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(b)(4).Complaint sample was visually inspected and the reported event of debris in packaging was confirmed.A review of the device history records did not identify any deviations or anomalies during the manufacturing process.The root cause of the reported event is the operator not following instructions during the manufacturing process.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 report 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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