SMITH & NEPHEW, INC. MOTOR DRIVE UNIT NON-HAND CNTL PWRMX; SAW, POWERED, AND ACCESSORIES
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Model Number 72200617 |
Device Problems
Unintended Power Up (1162); Overheating of Device (1437)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/12/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Internal complaint reference case-2020-00028584-1.
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Event Description
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It was reported that, during set up for a knee procedure, the motor drive unit was running without the foot pedal being activated.Additionally, it also got warm.The malfunction was solved with no delays or patient harm using a back up device.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, intended for use in treatment, was received for evaluation.There was no relationship found between the returned device and the reported incident, 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 did not fail for intermittent start/stop but did fail 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 of overheating 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.
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Search Alerts/Recalls
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