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 12/08/2022 |
Event Type
malfunction
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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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Event Description
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It was reported that during surgery, the device was leaking air.Another device was used to complete the surgery.There was a 0-15 minute delay and the patient was under anesthesia during that delay.No harm was reported.There were no adverse events associated with the malfunction.Due diligence is complete and there is no additional information available at this time.
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Manufacturer Narrative
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This complaint is recorded by zimmer biomet under (b)(4).Review of the most recent repair record determined the swivel was loose.The device was scrapped as requested.Review of the device history record identified no deviations or anomalies during manufacturing.A definitive root cause cannot be determined.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 is no additional information available regarding the event.
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Search Alerts/Recalls
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