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Model Number N/A |
Device Problems
Inability to Irrigate (1337); Noise, Audible (3273)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/30/2021 |
Event Type
malfunction
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Manufacturer Narrative
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This event has been recorded by zimmer biomet under (b)(4).(b)(6).Investigation is complete.This is an initial final report submission.Functional testing of the device confirmed the suction was not working and the motor made a high pitched noise.Visual inspection of the interior of the hand piece found the motor mounts were melted and warped, dropping the motor out of position and preventing the pinion gear from making contact with the face gear.There were yellow/brown marks found on the corners of the motor mounts.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 during the surgery, this complaint product did not spray saline water although the motor was working from the start of use.The complaint product also made abnormal noise during use.There was no harm reported but a 0-15 delay in procedure to prepare an alternate device.At product evaluation investigation yellow/brown markings were found on the mounts, indicating charring.No adverse events were reported as a result of this malfunction.
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Search Alerts/Recalls
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