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Model Number N/A |
Device Problems
Thermal Decomposition of Device (1071); Failure to Power Up (1476); Smoking (1585)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/27/2023 |
Event Type
malfunction
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Manufacturer Narrative
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This event has been recorded by zimmer biomet under (b)(4).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, unit will not power on even when connected to the wall.Evidence of smoke and charring present on power inlet module.No patient involved an no impact to user.Due diligence information complete.No additional information 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.The following sections were updated/corrected: review of the most recent repair record determined the unit was confirmed to not power on from wall power.The power inlet module showed signs of smoke and had melted and charred.The power inlet module was replaced and resolved the reported issue.Review of the device history record identified no deviations or anomalies during manufacturing related to the reported event.The root cause of the reported issue is attributed to a component failure.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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