Model Number N/A |
Device Problem
Failure to Cut (2587)
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Patient Problems
No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/16/2020 |
Event Type
malfunction
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Manufacturer Narrative
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This event has been recorded by zimmer biomet under (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 was reported that the device does not take a smooth graft during testing on (b)(6) 2020.No adverse events were reported as a result of this malfunction.
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Event Description
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No additional event information.
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Manufacturer Narrative
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This event has been recorded by zimmer biomet under (b)(4).This medwatch is being filed to relay additional information.Review of the most recent repair record determined the rpms were shaky.The spring seal was replaced and resolved the reported issue.Device is used for treatment.A definitive root cause cannot be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this event.The event is confirmed.
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Search Alerts/Recalls
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