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

Catalog Number 72200616

Device Problem Physical Resistance/Sticking (4012)

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

Event Date 11/12/2018

Event Type  malfunction  

Event Description

It was reported that the device button was sticking.The device was running continuously.No significant delay or patient injury were reported.Back up device was available.

Manufacturer Narrative

The device was received for evaluation.There was no relationship found between the returned device and the reported incident.A visual inspection was performed on the product and no issue was observed.Complaint of running continuously could not be reproduced due to jammed motor/gearbox.Product failed functional testing with blade stall error and overheating.Cause of blade stall (jamming) and overheating 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 of sticking was not confirmed and the root cause could not be determined since the reported malfunction could not be duplicated during the product evaluation process.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.

• 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 ; 5123585706
• MDR Report Key: 8145462
• MDR Text Key: 129778531
• Report Number: 1643264-2018-00956
• Device Sequence Number: 1
• Product Code: HAB
• UDI-Device Identifier: 03596010555472
• UDI-Public: 03596010555472
• 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: health professional,user faci
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 72200616
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/02/2019
• 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: N
• Patient Sequence Number: 1