Model Number N/A |
Device Problem
Problem with Sterilization (1596)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 03/15/2019 |
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 upon incoming inspection at the distributorship, that debris was found in the sterile package.No adverse events have been reported as a result of the malfunction.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.Complaint sample was evaluated and the reported event was confirmed.The returned product was visually inspected and the reported event (debris in packaging) was confirmed.Device history record was reviewed and no discrepancies were found.The likely condition of the product when it left zimmer biomet control was non-conforming.The root cause of the reported event is the operator not following instructions during the manufacturing process.A corrective action was initiate to address the manufacturing deficiency.This product falls within the scope of a corrective action which is reviewing all bridgend complaints for debris in packaging.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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