Model Number N/A |
Device Problems
Battery Problem (2885); Device Contaminated During Manufacture or Shipping (2969)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/20/2023 |
Event Type
malfunction
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Manufacturer Narrative
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This event has been recorded by zimmer biomet under (b)(4).G2 foreign: china evaluation and investigation is 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 before surgery it was found that the device had black powders inside the packaging from the battery pack.There was no patient involvement.Diligence is complete.No additional information is available.No adverse events were reported as a result of this malfunction.
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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).This medwatch is being filed to relay additional information.Visual examination of the returned product/provided pictures identified the battery pack was busted open and there were pieces of electrodes as well as black debris from the battery expulsion throughout the tyvek tray.The batteries were removed from the pack, therefore it could not be determined if they were in the correct orientation.Due to the damage from the expulsion, it could not be determined if there was damage present to the wiring before the expulsion.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 manufacturing issue.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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