Model Number N/A |
Device Problem
Delivered as Unsterile Product (1421)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 01/14/2019 |
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 that the stem had perforated the inner package, thus making the stem unusable.Attempts have been made and no further information has been provided.No adverse events have been reported as a result of the malfunction.
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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.Complaint sample was evaluated and the reported event was confirmed.The outer box was torn and the sterile tray was found punctured.Dhr was reviewed and no discrepancies relevant to the reported event were found.The likely condition of the product when leaving zimmer biomet was conforming to specifications.The root cause of the reported issue is attributed to transit damage.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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Search Alerts/Recalls
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