Model Number N/A |
Device Problem
Unsealed Device Packaging (1444)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 01/16/2019 |
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 during the surgery, the screw sterile packing seal was found to be not sealed completely.There was no patient impact as a result of the malfunction.No additional information is made available from this event.
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Manufacturer Narrative
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The following report is being submitted to relay additional information received.The visual inspection of the returned product identified that the sterile pouch was not sealed on one side.The reported event is confirmed.Review of the device history records for identified no deviations or anomalies.The root cause of the reported issue is attributed to operator error during the manufacturing process.Additional actions have been initiated through corrective action process.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 additional information is available to report.
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Search Alerts/Recalls
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