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Model Number N/A |
Device Problem
Calibration Problem (2890)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/14/2023 |
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: singapore.Review of the most recent repair record determined the unit had low speed and was out of calibration.The motor, handpiece switch, bearing pack, seal and reciprocating 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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It was reported that outside of surgery the device needed annual calibration and maintenance.There was no patient involvement, during the investigation, the unit had low speed.Due diligence information complete.No additional information is available.
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Search Alerts/Recalls
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