Model Number N/A |
Device Problem
Delivered as Unsterile Product (1421)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/28/2023 |
Event Type
malfunction
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Manufacturer Narrative
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This event is recorded by zimmer biomet under (b)(4).G2, country event occurred in: japan.The product is in the process of being evaluated by zimmer biomet.Once the product investigation has been completed, a follow up/final report will be submitted.Multiple mdr reports were filed for this event, please see associated reports: mfr - 0001526350-2023-01185.Mfr - 0001526350-2023-01186.Mfr - 0001526350-2023-01187.Mfr - 0001526350-2023-01188.
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Event Description
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It was reported that during receiving/inspection that the unit was observed to have debris in the package.There was no harm or injury as there was no patient involvement.Due diligence is complete.No additional information is available.No adverse event reported.
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Manufacturer Narrative
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This event is recorded by zimmer biomet under (b)(4).Visual examination of the returned product/provided pictures identified there was debris within the sealed packaging.Review of the device history record identified no deviations or anomalies during manufacturing.A definitive root cause cannot be determined.The event cannot be confirmed.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.Multiple mdr reports were filed for this event, please see associated reports: mfr - 0001526350 - 2023 - 01185-1.Mfr - 0001526350 - 2023 - 01186-1.Mfr - 0001526350 - 2023 - 01187-1.Mfr - 0001526350 - 2023 - 01188-1.
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Event Description
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No additional information is available regarding the incident.
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Search Alerts/Recalls
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