ZIMMER SURGICAL, INC. FAN SPRAY KIT; DISPOSABLE BATTERY-POWERED SURGICAL/ORTHOPAEDIC LAVAGE SYSTEM
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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 11/30/2021 |
Event Type
malfunction
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Event Description
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It was reported that the new fan spray kit make sound but didn't spray when the surgeon turned on the switch.The event timing was during surgery.There was no harm or delay reported.Upon inspection, there were yellow/brown marks found on the corners of the motor mounts.The discoloration was likely the result of burning, charring, smoke, etc.No adverse events were reported as a result of this malfunction.
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Manufacturer Narrative
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This complaint is recorded by zimmer biomet under (b)(4).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.No other damage was found.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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