MAUDE Adverse Event Report: SMITH & NEPHEW, INC. RFB MDU NON-HAND CNTL ELITE; SAW, POWERED, AND ACCESSORIES

Catalog Number	72200617F
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	05/06/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the motor drive unit shaver handle was not working when plugged in.No case involved.Preliminary results of investigation have concluded that this unit had a blade stall and was not running which makes it a reportable event.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
The reported device, intended for use in treatment, was received for evaluation.A visual inspection was performed on the product and no issue was observed.There was a relationship found between the returned device and the reported incident.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.The complaint was confirmed and the root cause has been determined to be corrosion of the motor and gearbox assembly.A blade stall condition will result in increased current draw from the control unit which will heat the motor and hand piece housing.Factors which can contribute to gearbox corrosion include cleaning and sterilization methods and the chemicals involved.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.A complaint history review concluded this was a repeat issue.
Event or Problem Description
It was reported that the motor drive unit shaver handle was not working when plugged in.No case involved.Results of investigation have concluded that this unit had a blade stall and was not running which makes it a reportable event.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

• Brand Name: RFB MDU NON-HAND CNTL ELITE
• Common Device Name: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107
• MDR Report Key: 10262240
• Report Number: 1643264-2020-00537
• Device Sequence Number: 19698813
• Product Code: HAB
• UDI-Device Identifier: 03596010608956
• UDI-Public: 3596010608956
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 72200617F
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2020
• Initial Date Received by Manufacturer: 06/19/2020
• Supplement Date Received by Manufacturer: 08/05/2020
• Initial Report FDA Received Date: 07/12/2020
• Supplement Report FDA Received Date: 08/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1