Catalog Number 214227160 |
Device Problem
Device Contaminated During Manufacture or Shipping (2969)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/04/2023 |
Event Type
malfunction
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Event Description
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It was reported that during an incoming inspection at the zimmer biomet japan distributorship, approximately three (3) weeks ago, the product was found to have debris in the sterile package.There was no patient involvement with this event.Attempts have been made, and no further information has been provided.
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Manufacturer Narrative
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(b)(4).G2: foreign - event occurred in japan zimmer biomet has received the product, and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.A supplemental will be filed accordingly if any further information is found that would change or alter any conclusions or information.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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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Visual examination of the returned product found debris in the sealed sterile packaging.Reported event did not occur in an operating room or as part of a medical procedure; medical records are not available for review.Review of the device history records identified no deviations or anomalies during manufacturing.The condition of the device when it left zimmer biomet is considered non-conforming to specification.The root cause of the reported event can be attributed to packaging operator not following the work instructions provided.If any further information which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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Search Alerts/Recalls
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