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 11/10/2023 |
Event Type
malfunction
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Manufacturer Narrative
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This event has been recorded by zimmer biomet under (b)(4) g2 foreign: japan multiple mdr reports were filed for this event, please see associated report: 0001526350-2023-01612, 0001526350-2023-01614 evaluation and investigation is in process.Once the investigation is complete, a supplemental report will be filed.
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Event Description
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It was reported that during incoming inspection at the zb warehouse a foreign and hair like substance was found in the packaging.There was no patient involvement.Diligence is complete.No additional information is available.No adverse events were reported as a result of this malfunction.
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Manufacturer Narrative
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This event has been recorded by zimmer biomet under (b)(4).Multiple mdr reports were filed for this event, please see associated report: 0001526350-2023-01612-1, 0001526350-2023-01614-1.This medwatch is being filed to relay additional information.Visual inspection confirmed there was hair-like debris inside the sealed package of the tips.Review of the device history record identified no deviations or anomalies during manufacturing related to the reported event.A definitive root cause cannot be determined.The event is 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.
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Event Description
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No additional event information available.
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Search Alerts/Recalls
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