Model Number N/A |
Device Problem
Battery Problem (2885)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/11/2023 |
Event Type
malfunction
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Manufacturer Narrative
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An investigation into the reported event has been initiated under cmp-0902465.Once the investigation has been completed, a follow up report will be submitted with the investigation results and any actions taken by the manufacturer.Multiple mdr reports were filed for this event, please see associated reports: 0001526350-2023-01449, 0001526350-2023-01450, 0001526350-2023-01451.
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Event Description
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It was reported that during surgery the battery was leaking acid upon opening.There was no patient harm and no delay noted.An alternate device was utilized to complete the procedure.Due diligence is in process and there is no additional information available.There was 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).A total of 4 devices were returned.Only one was opened.Functional testing found the opened device would not power on with the original battery pack but did power on and function normally in both modes when connected to a lab battery pack.Visual inspection of the interior of the pack found the batteries had leaked electrolyte inside of the pack.The other 3 were sealed in package and had no visible damage or 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 manufacturing process.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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