Model Number N/A |
Device Problems
Battery Problem (2885); Activation Problem (4042)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/25/2023 |
Event Type
malfunction
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Manufacturer Narrative
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This complaint is recorded by zimmer biomet under (b)(4).A follow up/ final report will be submitted once investigation is complete.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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It was reported that the unit does not work at all in either high or low mode.Battery was leaking.There is no harm or delay reported.The event timing was during surgery.No adverse events were reported as a result of this malfunction due diligence is complete and no additional information is available.
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Manufacturer Narrative
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G2: foreign country - japan.Functional testing of the returned product found the device powered on, primed in under 10 seconds, and functioned normally in both high and low modes when connected to the original battery pack.No issue or damage was found.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.A definitive root cause cannot be determined as there was no problem found.The event cannot be 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.
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Search Alerts/Recalls
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