MAUDE Adverse Event Report: SMITH & NEPHEW, INC. MOTOR DRIVE UNIT, HAND CNTRL, PWRMX EL SAW, POWERED, AND ACCESSORIES

Catalog Number 72200616S

Device Problems Hole In Material (1293); Overheating of Device (1437); Smoking (1585)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/31/2018

Event Type  Malfunction  

Event Description

It was reported that the shaver box and handpiece both got extremely hot shortly after being plugged in - without being used. The shaver hand piece cord burned a hole in the mayo stand cover and it began to smoke. No patient injury or significant time delay reported.

Manufacturer Narrative

Investigator determined that there was a relationship found between the returned device and the reported incident for overheating. Product failed functional testing with motor stall error and overheating. Cause of overheating and errors is a corroded motor/gearbox. The motor/gearbox assembly was removed from the housing and the gearbox was 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 motor 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 visual inspection was performed and no issues were noted.

• Brand Name: MOTOR DRIVE UNIT, HAND CNTRL, PWRMX EL
• Type of Device: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107 6512
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107 6512
• Manufacturer Contact: jim gonzales ; 7000 west william cannon drive; austin, TX 78735
• MDR Report Key: 7251498
• MDR Text Key: 99607151
• Report Number: 1643264-2018-00120
• Device Sequence Number: 1
• Product Code: HAB
• Combination Product (Y/N): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: COMPANY REPRESENTATIVE,USER F

Reporter Occupation

• Type of Report: Initial,Followup,Followup
• Report Date: 04/19/2018

1 Device Was Involved in the Event

0 PatientS WERE Involved in the Event:

• Date FDA Received: 02/08/2018
• Is This An Adverse Event Report?: No
• Is This A Product Problem Report?: Yes
• Device Operator: HEALTH PROFESSIONAL
• Device Catalogue Number: 72200616S
• Was Device Available For Evaluation?: Device Returned To Manufacturer
• Date Returned to Manufacturer: 04/16/2018
• Is The Reporter A Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 04/12/2018
• Was Device Evaluated By Manufacturer?: Device Not Returned To Manufacturer
• Is The Device Single Use?: No
• Is this a Reprocessed and Reused Single-Use Device?: No

Type of Device Usage