Model Number N/A |
Device Problems
Device Damaged Prior to Use (2284); Device Contamination with Chemical or Other Material (2944)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 12/22/2017 |
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.Not returned to manufacturer.
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Event Description
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It was reported that upon handling the product out of its packaging, it was noticed that there was an abnormal metal fragment protruding.There was no breach in sterility, however the device was not implanted.The surgery was completed with another device.No further information is available at this time.
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Manufacturer Narrative
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Report source: (b)(6).Reported event was confirmed by testing of device returned.Visual inspection of the device showed a protruding fiber metal wire near the rim feature of the shell.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.Investigation results concluded that the reported event was due to a manufacturing deficiency.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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Search Alerts/Recalls
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