SMITH & NEPHEW, INC. MOTOR DRIVE UNIT HAND CNTRL PWRMX EL; SAW, POWERED, AND ACCESSORIES
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Model Number 72200616 |
Device Problems
Failure to Power Up (1476); Mechanical Jam (2983)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/07/2021 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).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 observed no issues.A functional evaluation revealed a jammed motor/blade stall.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.The complaint was confirmed and the root cause has been associated with a mechanical component failure.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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Event Description
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It was reported that the motor drive unit, hand cntrl, pwrmx el did not turn on.No case reported; therefore, there was no patient involvement.Results of investigation have concluded that this unit had a jammed motor/blade stall error 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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Search Alerts/Recalls
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