SMITH & NEPHEW, INC. DYONICS POWERMINI, WITH HAND CONTROLS; SAW, POWERED, AND ACCESSORIES
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Catalog Number 72201500 |
Device Problem
Overheating of Device (1437)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/26/2024 |
Event Type
malfunction
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Event Description
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It was reported that, during a tmj arthroscopy, the dyonics powermini device was overheating.Surgery was completed with a smith+nephew coblator wand instead.There was a surgical delay of less than 30 minutes, and no further complications were reported.
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Manufacturer Narrative
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H10: internal complaint reference number: (b)(4).
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Manufacturer Narrative
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H3, h6: the reported device was received for evaluation.A visual inspection was performed on the exterior of product and no physical damage was observed.A functional evaluation was performed on the returned device and a noisy motor was found and motor began to get hot.Further evaluation revealed a corroded gearbox.These failures have been determined to be related to the reported event.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specifications upon release for distribution.A complaint history review found similar reported events.A risk management review found that the reported failure and/or harm was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.The root cause was associated with corrosion in the gearbox.Factors that could have contributed to the reported event include a blade stall condition that will result in increased current draw from the control unit which will heat the motor and handpiece housing.This can be the result of gearbox corrosion caused by cleaning and sterilization methods and the chemicals involved.No containment or corrective actions are recommended at this time.
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Search Alerts/Recalls
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