Model Number N/A |
Device Problems
Inability to Irrigate (1337); Mechanical Problem (1384); Device Emits Odor (1425); Smoking (1585)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/18/2021 |
Event Type
malfunction
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Manufacturer Narrative
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This event has been recorded by zimmer biomet under (b)(4).Once the investigation is completed, a follow-up/final report will be submitted.
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Event Description
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It was reported that the device was running poorly and it smelled like burns.There was no damage to the connections.The event occurred during surgery, there was no harm or delay.From the beginning the device was running poorly and after a while, spraying stopped.It smelled like burn and smoke was seen around the battery pack.No adverse events were reported as a result of this malfunction.
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Event Description
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There is no additional information.
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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.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record identified no deviations or anomalies during manufacturing related to the reported event.Device is used for treatment.A definitive root cause cannot be determined.The event cannot be confirmed.
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Search Alerts/Recalls
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