MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SVCE REPL MDU CNTRL PWRMX ELITE; SAW, POWERED, AND ACCESSORIES

Catalog Number 72200616SR

Device Problem Overheating of Device (1437)

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

Event Date 12/19/2016

Event Type  malfunction  

Event Description

It was reported that the mdu hand control was overheating during a knee procedure.A backup device was used to complete the procedure, and no delay was noted.No injury or complications were reported.

Manufacturer Narrative

A functional evaluation was performed and presented a motor stall error and heating of the hand piece.Corrosion was observed on the cable assembly connection.The motor/gearbox assembly could not be removed from the housing for further assessment due to corrosion.The root cause of this event was identified to be associated with 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.

• Brand Name: SVCE REPL MDU CNTRL PWRMX ELITE
• 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 w william cannon dr.; austin, TX 78735 ; 5123585706
• MDR Report Key: 6214490
• MDR Text Key: 63821079
• Report Number: 1643264-2016-00313
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 12/21/2016

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
• Device Operator: Health Professional
• Device Catalogue Number: 72200616SR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/21/2016
• Initial Date FDA Received: 12/29/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/26/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/15/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1