Model Number N/A |
Device Problems
Thermal Decomposition of Device (1071); Melted (1385); Electrical Shorting (2926)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/30/2023 |
Event Type
malfunction
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Manufacturer Narrative
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An investigation into the reported event has been initiated under (b)(4).Once the investigation has been completed, a follow up report will be submitted with the investigation results and any actions taken by the manufacturer.
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Event Description
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It was reported that outside of surgery, it was observed that where the cord plugs in, it was melted and burnt.The power inlet module shorted out.There was no patient involvement.Due diligence is complete and there is no additional information available.There is no adverse event associated with this malfunction.
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Manufacturer Narrative
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This complaint is recorded by zimmer biomet under (b)(4).0001954182-2023-00073-1.Review of the most recent repair record determined the unit was confirmed to have a melted and burnt power inlet module, power cord, and power inlet module cable.The power inlet module, power cord, and power inlet module cable 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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Event Description
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There is no additional information available regarding the event.
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Search Alerts/Recalls
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