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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