SMITH & NEPHEW, INC. MOTOR DRIVE UNIT, HAND CNTRL, PWRMX EL; SAW, POWERED, AND ACCESSORIES
|
Back to Search Results |
|
Catalog Number 72200616 |
Device Problems
Mechanical Problem (1384); Overheating of Device (1437)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 05/01/2023 |
Event Type
malfunction
|
Event Description
|
It was reported that during a shoulder arthroscopy, the mdu was not working when it was plugged in.There was an error message: handpiece overheating.The procedure was completed with a s+n back up device.There was no surgical delay and no further complications were reported.
|
|
Manufacturer Narrative
|
H10: internal complaint reference number: (b)(4).H3, h6: the reported device was received for evaluation.A visual inspection was performed on the exterior of product and no physical damage was observed.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.
|
|
Search Alerts/Recalls
|
|
|