SMITH & NEPHEW, INC. DYONICS POWERMINI, WITH HAND CONTROLS; SAW, POWERED, AND ACCESSORIES
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Model Number 72201500 |
Device Problems
Overheating of Device (1437); Material Deformation (2976); Mechanical Jam (2983)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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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 the 'dyonics powermini shaver' gearbox clicks, jams and overheats.No case reported; therefore, there was no patient involvement.
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Manufacturer Narrative
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H3.H6: the reported device was received for evaluation.There was a relationship found between the returned device and the reported event.A visual inspection found a bent guide key inside mdu connector.Unable to test due to bent guide key in inside mdu connector.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.A complaint history review found similar reported events.A risk management review found that the reported failure was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.The complaint of overheating and mechanical jam was not confirmed, and the root cause could not be determined as the condition in which the device was received did not allow for evaluation of the reported complaint.Factors which can contribute to overheating include a blade stall condition that will result in increased current draw from the control unit which will heat the motor and hand piece housing.This can be the result of gearbox corrosion caused by cleaning and sterilization methods and the chemicals involved.The complaint of damaged connector was confirmed, and the root cause was associated with unintended use of the device.Factors that could have contributed to a damaged connector include excessive force, misalignment, or twisting of the connector during connection/disconnection to a control unit.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.No containment or corrective actions are recommended at this time.
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Event Description
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It was reported that the 'dyonics powermini shaver' gearbox clicks, jams and overheats.No case reported; therefore, there was no patient involvement.Results of investigation found a bent guide key inside mdu connector.
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Search Alerts/Recalls
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