Catalog Number 010000662 |
Device Problem
Packaging Problem (3007)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/15/2021 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Product has been received by zimmer biomet and 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 the sterile package was opened and the item was implanted.The scrub nurse tech examined the sterile packaging and noticed a piece of hair.The surgeon decided to explant the item.Attempts have been made and 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.The following sections were updated/corrected updated: visual evaluation of the photos provided and returned product identified a hair-like debris.The debris was found by the customer after the sterile packaging was opened, and therefore, the origin of the debris cannot be confirmed.No further evaluation was performed.Device history record (dhr) was reviewed and no discrepancies were found.Root cause of the event could not be determined as the product was returned opened.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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