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Model Number N/A |
Device Problem
Packaging Problem (3007)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/25/2023 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Report source: japan.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 during incoming inspection at zb warehouse in japan, a team member found debris in the sterile packaging.No reported patient involvement.
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Manufacturer Narrative
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Visual examination of the returned product found one pouch contains foreign debris that exceeds.60 sq.Mm., which is not acceptable per review of zpc 8.400.This complaint has been confirmed.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.Reported event did not occur in an operating room or as part of a medical procedure; medical records are not available for review.The condition of the device when it left zimmer biomet is non-conforming to specification.The root cause of the reported event is the operator not following the work instructions provide.If any further information is found 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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