SMITH & NEPHEW, INC. MOTOR DRIVE UNIT, HAND CNTRL, PWRMX EL; SAW, POWERED, AND ACCESSORIES
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Model Number 72200616 |
Device Problems
Unintended Power Up (1162); Overheating of Device (1437); Key or Button Unresponsive/not Working (4063)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/12/2022 |
Event Type
malfunction
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Event Description
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It was reported that the motor drive unit presented the motor keeps cutting in and out and the forward button doesn't work.The problem was noticed during set up, no delay or further complications were reported, and the procedure was finished with a smith and nephew back up device.
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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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H3, h6: the reported device was received for evaluation.There was a relationship found between the returned device and the reported event.A visual inspection found no issues.A functional evaluation revealed a blade stall error and overheating of the housing.Further evaluation revealed the drive fork was stiff when rotated.It was also noted during test the forward and reverse button was unresponsive.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.A complaint history review found similar reported events.A risk management review found that the reported failure was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.The complaint of overheating and intermittent energy output was confirmed, the root cause was associated with a mechanical component failure.Factors which can contribute to overheating include a blade stall condition that will result in increased current draw from the control unit which will heat the motor and hand piece housing.This can be the result of gearbox corrosion caused by cleaning and sterilization methods and the chemicals involved the complaint of unresponsive buttons was confirmed and the root cause has been associated with an electrical component failure.Factors that could have contributed to the reported event include an internal short or component failure of the hall board.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.No containment or corrective actions are recommended at this time.
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Search Alerts/Recalls
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