Model Number N/A |
Device Problem
Material Frayed (1262)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/22/2023 |
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.
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Event Description
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It was reported that outside of surgery, the device had an issue with the power cord where there were wires exposed.There was no patient involvement.Due diligence is complete and there is no additional information available.There was no adverse event associated with the malfunction.
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Event Description
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There is no additional information available regarding the event.
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Manufacturer Narrative
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This complaint is recorded by zimmer biomet under (b)(4).It was reported that the power cord had exposed wires.Review of the most recent repair record could not be completed because the device was not returned for evaluation and repair.Review of the device history record identified no deviations or anomalies during manufacturing.A definitive root cause cannot be determined.The event cannot be 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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Search Alerts/Recalls
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