ZIMMER SURGICAL, INC. HANDPIECE, ELECTRIC DERMATOME; DERMATOME HANDPIECE, ELECTRICALLY-POWERED
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Model Number N/A |
Device Problems
Component Missing (2306); Insufficient Information (3190)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/08/2022 |
Event Type
malfunction
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Event Description
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It was reported that during unknown timing, the product was determined to need service and it was missing parts.No harm or delay was noted.During product evaluation, it was found that the motor speed was unstable.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.No adverse events are associated with this 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 speed was unstable and the motor had signs of corrosion, the needle bearing was worn, and some screws were not original.The control bar was not in the correct position and the unit was not calibrated.The motor, needle bearing, and screws were replaced and the control bar position and unit were recalibrated to resolve 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).
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Search Alerts/Recalls
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