Model Number N/A |
Device Problem
Unstable (1667)
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Patient Problem
No Patient Involvement (2645)
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Event Date 08/03/2020 |
Event Type
malfunction
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Manufacturer Narrative
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This event has been recorded by zimmer biomet under (b)(4).Once an evaluation of this device is completed, a follow-up/final report will be submitted.(b)(6).
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Event Description
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It was reported during pre-surgery device check that the device was not working properly as the engine 'does not run well.There was no harm or delay involved.No adverse events were reported as a result of this malfunction.
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Event Description
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There is no additional information.
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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 the motor did not run and needed replacement; however, the repair was not completed because it is awaiting approval by the customer.Review of the device history record identified no deviations or anomalies during manufacturing.Device is used for treatment.A definitive root cause cannot be determined.The event is confirmed.
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Search Alerts/Recalls
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