Model Number N/A |
Device Problems
Tear, Rip or Hole in Device Packaging (2385); Difficult to Open or Remove Packaging Material (2922)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 05/27/2020 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
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Event Description
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It was reported the affixus cortical screw did not open properly.Internal package ripped upon attempting to open.Surgeon deemed item not fit for implantation in case contamination occurred.
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Manufacturer Narrative
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(b)(4).Reported event was considered confirmed via visual evaluation.Device history record was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause could not be determined.This event was farther investigated through the capa process.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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Event Description
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No further event information available at the time of this report.
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Search Alerts/Recalls
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