SMITH & NEPHEW, INC. MOTOR DRIVE UNIT HAND CNTRL PWRMX EL; SAW, POWERED, AND ACCESSORIES
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Catalog Number 72200616 |
Device Problem
Sparking (2595)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 01/24/2020 |
Event Type
malfunction
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Event Description
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It was reported that the surgeon had bent the tip of the shaver that was being used on the motor drive unit.As he took the handpiece out of the joint and tech was switching from shaver to burr, a spark flew out of the handpiece.The procedure was successfully completed without significant delay using a back up device.No patient injury or other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
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Manufacturer Narrative
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H10 h3,h6: the reported device, used in treatment, was received for evaluation.A visual inspection was performed on the product and no issue was observed.There was no relationship found between the returned device and the reported incident.Complaint of electrical short could not be confirmed.Product failed functional testing with blade stall error and overheating.Cause of overheating and errors is a corroded motor/gearbox.The housing and the gearbox were removed from the motor.The gearbox was found to be jammed.Electrical short did not occur during functional testing.The complaint was not confirmed and the root cause could not be determined since the reported malfunction could not be duplicated during the product evaluation process.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.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.
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Search Alerts/Recalls
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