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Model Number N/A |
Device Problem
Power Problem (3010)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/31/2023 |
Event Type
malfunction
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Event Description
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It was reported that, prior to surgery on (b)(6) 2023, device had an electrical issue.Investigation found device had inconsistent speed.There was no patient involvement, harm, or impact.Due diligence information complete.
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Manufacturer Narrative
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This event has been recorded by zimmer biomet under (b)(4).G2: foreign: france e1: telephone: (b)(6).Review of the most recent repair record determined the motor speed unstable and the insulation of the plug harness assembly was damaged.The motor and plug harness assembly were replaced and resolved the reported issue.Review of the device history record identified no deviations or anomalies during manufacturing related to the reported event.A definitive root cause cannot be determined.The event is 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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