Model Number N/A |
Device Problem
Gas/Air Leak (2946)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/20/2023 |
Event Type
malfunction
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Event Description
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It was reported that the unit was leaking air at the hose and handpiece connection.There was no patient harm/injury.There was no information provided regarding the timing of the event.Due diligence is complete; no further information is available.
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Manufacturer Narrative
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An investigation into the reported event has been initiated under (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.
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Manufacturer Narrative
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This event has been recorded by zimmer biomet under (b)(4).Review of the most recent repair record identified no repairs related to the reported event.The reported issue could not be duplicated.Review of the device history record identified no deviations or anomalies during manufacturing related to the reported event.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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