Model Number N/A |
Device Problems
Unstable (1667); Calibration Problem (2890)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/17/2023 |
Event Type
malfunction
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Manufacturer Narrative
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This event has been recorded by zimmer biomet under (b)(4).E1 telephone number: (b)(6).G2 foreign: poland.Evaluation and investigation are in process.Once the investigation is complete, a supplemental report will be filed.
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Event Description
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It was reported that during maintenance inspection on (b)(6) 2023, we have received the following unit to maintenance but repair is needed for calibration issue, motor issue, motor speed unstable.There was no patient involved and no impact or harm reported.Due diligence information in process.
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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) review of the most recent repair record determined the unit was out of calibration and the motor speed was unstable.The motor, shaft bearings, screws and sleeve bearings 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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