Model Number N/A |
Device Problem
Power Problem (3010)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/12/2022 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Report source - foreign: (b)(6).The customer has indicated that the product will be returned to zimmer biomet and the investigation is in process.Once the investigation has been completed, a supplemental medwatch 3500a will be submitted.H3 other text : investigation incomplete.
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Event Description
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It was reported unit does not have consistent power.No additional information is available on timing as the unit was identified as needing repair.There was no patient involvement.It was reported that no further information is available.
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Manufacturer Narrative
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This event has been recorded by zimmer biomet under: (b)(4).This medwatch is being filed to relay additional information.Review of the most recent repair record identified no repairs related to the reported event.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 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.
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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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