Model Number N/A |
Device Problem
Failure to Cut (2587)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 09/15/2020 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Once an evaluation of this device is completed, a follow-up/final report will be submitted.
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Event Description
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It has been reported that the device was snagging and causing tears during surgery.There was no harm or delay reported.No adverse events were reported as a result of this malfunction.
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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.Device is used for treatment.A review of the device history records and a complaint history review will not be completed for limited investigation complaints as the product meets the applicable acceptance criteria a definitive root cause cannot be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this event.The event cannot be confirmed.
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Event Description
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No additional event information.
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Search Alerts/Recalls
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