ZIMMER SURGICAL, INC. HANDPIECE, ELECTRIC DERMATOME; DERMATOME HANDPIECE, ELECTRICALLY-POWERED
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Model Number N/A |
Device Problems
Unstable (1667); Naturally Worn (2988); Power Problem (3010)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/28/2023 |
Event Type
malfunction
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Event Description
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It was reported during preventative maintenance, the device had a motor speed issue and worn screw.The motor speed was unstable, and the motor also failed the voltage test.There was no patient involvement.Due diligence is complete as multiple attempts were made; however, no further information is available.As no additional information is available, we are unable to provide further information.There are no adverse events associated with this malfunction.
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Manufacturer Narrative
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An investigation into the reported event has been initiated under cmp-(b)(4).Once the investigation has been completed, a follow up report will be submitted with the investigation results and any actions taken by the manufacturer.Initial reporter telephone number: (b)(6).
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Manufacturer Narrative
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This complaint is recorded by zimmer biomet under (b)(4).Review of the most recent repair record determined the motor was corroded and failed the voltage test, the motor speeds were unstable, and a screw was worn.The motor and screw were replaced and resolved the reported issue.Review of the device history record identified no deviations or anomalies during manufacturing.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.G2 country: united kingdom.
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Event Description
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There is no additional information available regarding the event.
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