ZIMMER SURGICAL, INC. HANDPIECE, ELECTRIC DERMATOME; DERMATOME HANDPIECE, ELECTRICALLY-POWERED
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Model Number N/A |
Device Problems
Material Integrity Problem (2978); Insufficient Information (3190)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/03/2023 |
Event Type
malfunction
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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 speeds were unstable and the insulator was damaged.The motor and insulator 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.E1 telephone number: (b)(6).G2 country: poland.
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Event Description
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It was reported that during preventative maintenance, it was observed that there was an issue with the motor and the insulator was damaged.During product evaluation, it was discovered that the motor speed was unstable.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 was no adverse event associated with this malfunction.
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Search Alerts/Recalls
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