SMITH & NEPHEW, INC. MOTOR DRIVE UNIT, HAND CNTRL, PWRMX EL; SAW, POWERED, AND ACCESSORIES
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Catalog Number 72200616 |
Device Problems
Corroded (1131); Overheating of Device (1437); Noise, Audible (3273)
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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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H10: internal complaint reference: (b)(4).
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Event Description
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It was reported that the mdu had loud sounds and it was overheating.No case was reported, therefore, there was not patient involvement.
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Manufacturer Narrative
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H3, h6: the reported device was received for evaluation.A visual inspection revealed a discolored cable.Discolored cable is a cosmetic issue that does not affect device functionality and it is not related to the alleged failure.A functional evaluation was performed on the returned device and found a noisy motor was found.Further evaluation revealed a corroded gearbox.These findings 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 a mechanical component failure.Factors that could have contributed to the failure 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.No containment or corrective actions are recommended at this time.
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Search Alerts/Recalls
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