SMITH & NEPHEW, INC. MOT DR UNIT HNDCONT POWERMAX ELITE; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
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Catalog Number 72200872 |
Device Problem
Mechanical Jam (2983)
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Patient Problem
No Information (3190)
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Event Date 05/06/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Device is under investigation by the manufacturing site.
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Event Description
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It was reported that during use in an unspecified procedure the motor drive unit was noisy.It is unknown what was the procedure being performed, but there was no complication or injury reported to the patient.Preliminary results of investigation have concluded that the blade stalled and the motor was not running which makes it a reportable event.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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The reported device, used 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 housing and the gearbox were removed from the motor.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.
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Search Alerts/Recalls
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