Model Number N/A |
Device Problem
Unsealed Device Packaging (1444)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 02/25/2020 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The device has been returned to zimmer biomet for investigation.The investigation is in process.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 an initial hip procedure the surgical team went to open a m/l taper stem, and there was no glue on the plastic container sealing the paper to the plastic.The paper was not tightly sealed to the plastic holding containing the implant.It was decided not to use the implant due to uncertainty of sterility.No adverse events have been reported as a result of this malfunction.Attempts were made to obtain additional information; however, none was available.
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Manufacturer Narrative
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Reported event was confirmed by visual examination of the device/packaging.Device history record (dhr) was reviewed and no discrepancies were found.The root cause of the reported issue is attributed to a manufacturing error.Visual evaluation of the returned product confirmed that no glue was applied to the sealing flange of the inner sterile cavity and the inner lid was not attached to the inner cavity.The sterility is compromised.The likely condition of the part when it left zimmer biomet control is considered non-conforming based on the evaluation of the returned product.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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