SMITH & NEPHEW, INC. DYONICS POWERMINI WITH HAND CONTROLS; SAW, POWERED, AND ACCESSORIES
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Model Number 72201500 |
Device Problems
Communication or Transmission Problem (2896); Mechanical Jam (2983)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/30/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Internal complaint reference (b)(4).
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Event Description
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It was reported that during ankle scope procedure the surgeon tried to press the debridement button of dyonics powermini with hand controls the device would not respond, and as gears (sounded like they were grinding), the actual disposable blade would not spin.The procedure was finished with a smith and nephew backup device.It is unknown if occurred a surgical delay.Patient injuries were not reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
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Manufacturer Narrative
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Internal complaint reference:(b)(4).The reported device, used in treatment, was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.A review of the device history records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A relationship, if any, between the subject device and the reported event could not be determined.No containment or corrective actions are recommended at this time.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.A complaint history review concluded this was a repeat issue.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.
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Manufacturer Narrative
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Internal complaint reference (b)(4).The reported device, intended for use in treatment, was received for evaluation.A visual inspection was performed on the product and no issue was observed.There was a relationship found between the returned device and the reported incident.Product failed functional testing with blade stall error and overheating.Cause of overheating and errors is a corroded motor/gearbox.The gearbox was found to be jammed.The complaint was confirmed and the root cause has been determined to be corrosion of the motor and gearbox assembly.A blade stall condition will result in increased current draw from the control unit which will heat the motor and hand piece housing.Factors which can contribute to gearbox corrosion include cleaning and sterilization methods and the chemicals involved.A review of the device history records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review concluded this was a repeat issue.No containment or corrective actions are recommended at this time.
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Search Alerts/Recalls
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