SMITH & NEPHEW, INC. MOTOR DRIVE UNIT, HAND CNTRL, PWRMX EL; SAW, POWERED, AND ACCESSORIES
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Catalog Number 72200616 |
Device Problems
Smoking (1585); Noise, Audible (3273); Unexpected Shutdown (4019)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/29/2023 |
Event Type
malfunction
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Event Description
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It was reported that the mdu was making a grinding sound, it was smoking, it then shut off.No case reported; therefore, there was no patient involved.
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Manufacturer Narrative
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Internal complaint reference: (b)(4).
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Manufacturer Narrative
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Internal complaint reference (b)(4).H3, h6: a device deficiency was not identified, and the root cause of the reported event could not be determined since the device was not returned for evaluation.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specifications upon release for distribution.A complaint history review found similar reported events.A risk management review found that the reported failure and/or harm was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.Please refer to the instructions for use for precautions and warnings related to the use of the device.No containment or corrective actions are recommended at this time.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.
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Manufacturer Narrative
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H10, h3, h6: the reported device was received for evaluation.A visual inspection revealed a discolored cable.Discolored cable is a cosmetic issue that does not affect device functionality and it is not related to the alleged failure.A functional evaluation was performed on the returned device and a noisy motor was found further evaluation revealed a corroded gearbox.No smoking or unexpected shutdown noted.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specifications upon release for distribution.A complaint history review found similar reported events.A risk management review found that the reported failure and/or harm was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.The root cause was associated with a mechanical component failure.The root cause was associated with a 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 a short in the power cord.No containment or corrective actions are recommended at this time.
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Search Alerts/Recalls
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