Model Number N/A |
Device Problems
Power Problem (3010); Appropriate Term/Code Not Available (3191); Intermittent Loss of Power (4016)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/08/2023 |
Event Type
malfunction
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Manufacturer Narrative
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This complaint is recorded by zimmer biomet under (b)(4).A follow up/ final report will be submitted once investigation is complete.G2: foreign country - sweden.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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Event Description
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It was reported that during surgery on (b)(6) 2023 slower phase when on and then stopped working for a few seconds then started working again at a slower phase.There was no harm or delay reported.Due diligence is complete and there is no additional information till date.
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Manufacturer Narrative
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Review of the most recent repair record determined the motor speed was unstable and there was corrosion on the needle bearing e-ring and reciprocation arm.The motor, needle bearing, e-ring, and reciprocation arm 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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Event Description
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There is no additional event information available.
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Search Alerts/Recalls
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