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 08/29/2023 |
Event Type
malfunction
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Manufacturer Narrative
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This event has been recorded by zimmer biomet under cmp-(b)(4).E1 telephone number:(b)(6).G2: foreign: lithuania evaluation and investigation are 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, outside of surgery on (b)(6) 2023, motor does not withstand nominated power.There was no patient involvement and no reported impact to user.Due diligence information complete.No additional information available.
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Event Description
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No additional event information available.
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Manufacturer Narrative
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This event has been recorded by zimmer biomet under (b)(4).Review of the most recent repair record determined the cable had contact issues and there was corrosion on the motor.The motor and plug harness assembly were replaced and resolved the reported issue.Review of the device history record identified no deviations or anomalies during manufacturing.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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Search Alerts/Recalls
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