Model Number N/A |
Device Problem
Intermittent Loss of Power (4016)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/05/2023 |
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: spain.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 at unknown event timing the product did not work correctly.The product stops.There is no report of harm or delay.Diligence is in process.No additional information has been received.No adverse events were reported as a result of this malfunction.
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Event Description
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It was reported that before surgery and before starting to work with the patient the device engine did not work.It stopped working.There was no patient involvement with no harm or delay.An additional skin graft was not needed.Diligence is complete.No additional 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.Evaluation and investigation is in process.Once the investigation is complete, a supplemental report will be filed.
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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 determined that the motor failed and the speed was unstable.The motor, switch, and plug harness were replaced and resolved the reported issue.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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Due diligence is complete and no additional information is available.
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Search Alerts/Recalls
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