Model Number N/A |
Device Problem
Material Frayed (1262)
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Patient Problems
No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/14/2020 |
Event Type
malfunction
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Manufacturer Narrative
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This event has been recorded by zimmer biomet under cmp-(b)(4).Once the investigation is complete, a follow up/final report will be submitted.
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Event Description
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It was reported that the front control panel has broken off and exposing wires.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).This medwatch is being filed to relay additional information.Once the investigation is complete, a follow up/final report will be submitted.
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Event Description
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No additional event information available.
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Manufacturer Narrative
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This event has been recorded by zimmer biomet under (b)(4).Visual examination of the returned product and provided pictures identified the helmet was missing the power button.Mechanical testing found the boa system would not retract so the headband could be loosened.Review of the device history record identified no deviations or anomalies during manufacturing related to the reported event.Device is used for treatment.A definitive root cause cannot be determined.The event is confirmed.
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Event Description
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No additional event information available.
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Search Alerts/Recalls
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