SMITH & NEPHEW, INC. MOTOR DRIVE UNIT, HAND CNTRL, PWRMX EL; SAW, POWERED, AND ACCESSORIES
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Catalog Number 72200616 |
Device Problems
Mechanical Problem (1384); Overheating of Device (1437); Intermittent Energy Output (4025)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Event Description
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It was reported that the mdu was with inconsistent performance.It seemed like the cable was cutting in and out the power.It is unknown whether the event happened during surgery, if there was patient involvement or if there was a surgical delay; however, there was a smith and nephew back up device available.No further complications were reported.
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Manufacturer Narrative
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H10: internal complaint reference number: (b)(4).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 revealed a blade stall error and overheating of the housing.Further evaluation revealed the drive fork was stiff when rotated.The root cause was associated with a mechanical component failure.Factors that could have contributed 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 could be the result of gearbox corrosion caused by cleaning and sterilization methods and the chemicals involved.Several corrective actions were taken to reduce the occurrence of this failure.No further actions are required at this time.
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Search Alerts/Recalls
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