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

Model Number 72200616

Device Problem Smoking (1585)

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

Event Type  malfunction  

Event Description

It was reported that the mdu started smoking during an orthopedics case.A backup device was available to complete the procedure with no delay or patient injuries.

Manufacturer Narrative

The device 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 motor/gearbox assembly could not be removed from the housing for further assessment due to corrosion.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.

Manufacturer Narrative

The initial incident report was submitted with incorrect manufacturing site information and registration number 3003604053 (b)(4).The correct manufacturing site information and registration number is 1643264(b)(4).

• 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: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 8814531
• MDR Text Key: 151845054
• Report Number: 3003604053-2019-00081
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 72200616
• Device Catalogue Number: 72200616
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/09/2019
• 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: Unknown
• Patient Sequence Number: 1