Catalog Number 42532006402 |
Device Problem
Device Contaminated During Manufacture or Shipping (2969)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 07/26/2018 |
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 there was foreign material inside the inner package.A new device was opened and used to complete the procedure.No adverse events have been reported as a result of the malfunction.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.(b)(4).Complaint sample was evaluated and the reported event was confirmed.Visual evaluation of the returned device confirmed that a hair was present between the foam protector and the inner cavity.The hair was found on the outside of the poly bag the product is packaged in.Dhr was reviewed and no discrepancies were found.The root cause of this issue was determined to be human error as this non-conformance was not detected as part of the inspection steps detailed in the packaging procedure.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 information available.
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Search Alerts/Recalls
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