SMITH & NEPHEW, INC. MOTOR DRIVE UNIT HAND CNTRL PWRMX EL; SAW, POWERED, AND ACCESSORIES
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Model Number 72200616 |
Device Problem
Material Twisted/Bent (2981)
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Patient Problem
No Patient Involvement (2645)
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Event Date 09/01/2020 |
Event Type
malfunction
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Event Description
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It was reported that the mdu had the pins bent.No case involved.Preliminary results of investigation revealed that during functional evaluation the motor jammed/blade stalled 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, intended for use in treatment, was received for evaluation.There was a relationship found between the returned device and the reported incident.A visual inspection was performed on the product and revealed a discolored cable.A functional evaluation revealed a jammed motor.The complaint was confirmed and the root cause has been associated with a mechanical component failure.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.Factors that could have contributed to the reported event include corrosion in the gearbox/motor assembly from cleaning and sterilization methods and the chemicals involved over a period of time or one or more of the motor phases shorting out.
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Search Alerts/Recalls
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