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 11/01/2023 |
Event Type
malfunction
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Manufacturer Narrative
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An investigation into the reported event has been initiated under cmp-(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.E1: telephone: (b)(6).G2: foreign: estonia.
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Event Description
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It was reported that before surgery during scrub nurse table preparation, they found the pulsavac hip kit batteries exploded.An alternate device was available to complete the surgery.There was no patient involvement.Due diligence is complete, no further information is available.
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Manufacturer Narrative
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This event has been recorded by zimmer biomet under (b)(4).Visual inspection of the product showed the battery pack was busted open and there were pieces of batteries as well as black debris from the battery expulsion throughout the tyvek tray.Batteries were in the correct orientation inside the pack.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 the 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 was no additional information available.
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Search Alerts/Recalls
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