Model Number N/A |
Device Problem
Delivered as Unsterile Product (1421)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/29/2023 |
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.G2: foreign: japan multiple mdr reports were filed for this event, please see associated report: 0001526350-2023-01644.
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Event Description
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It was reported that during surgery white powder was found inside of the sterile tray when the nurse opened the package.There was no patient harm or injury.There was no medical intervention.There was a 0¿15-minute surgical delay as the nurse prepared a backup of the same product for the surgery.Due diligence is complete; there is no additional information available.
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Manufacturer Narrative
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This event has been recorded by zimmer biomet under (b)(4).The device was returned opened but unused inside the original tyvek tray.Visual inspection confirmed there was a white debris on the tubing of the device.The white debris was visible at 12-18¿ under normal lighting with up to 10 second inspection.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.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.
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Search Alerts/Recalls
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