SMITH & NEPHEW, INC. MOTOR DRIVE UNIT, HAND CNTRL, PWRMX EL; SAW, POWERED, AND ACCESSORIES
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Model Number 72200616 |
Device Problems
Overheating of Device (1437); Mechanical Jam (2983); Noise, Audible (3273); Key or Button Unresponsive/not Working (4063)
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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 did not work when the button was clicked, and it sounded like it was stalling.It is unknown whether the event happened during surgery and if there was patient involvement.It is unknown if there was a delay or if a backup device was available and how the issue was resolved.Per results of investigation blade stall error, overheating of the housing a stiff drive fork when rotated were found.
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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 revealed a blade stall error and overheating of the housing.Further evaluation revealed the drive fork was stiff when rotated.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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