Catalog Number 89-8521-470-20 |
Device Problems
Overheating of Device (1437); Battery Problem (2885)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/09/2023 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Upon receipt, the device did not have power due to overheating.Review of the device history record identified no deviations or anomalies during manufacturing related to the reported event.Device is used for treatment.With given information, a definitive root cause cannot be determined.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 during a check at the repair centre, it was discovered that the battery did not have power due to overheating.Although this event occurred out of surgery, it is related to a malfunction that could potentially lead to a serious injury.However, no patient harm or further outcome was reported.No more information has been provided.
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Search Alerts/Recalls
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