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

Catalog Number 72200616

Device Problem Temperature Problem (3022)

Patient Problems Burn(s) (1757); Partial thickness (Second Degree) Burn (2694)

Event Date 06/14/2017

Event Type  Injury  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that during the knee arthroscopy the surgeon reached for the device and immediately noticed it was hot.Since the device was on the patient the surgeon checked the patient and noticed a small burn.The surgeon also burned his hand while reaching for the device.The healthcare professional claimed the handle wasn't turned on while it wasn't in use.

Event Description

It was reported that during the knee arthroscopy the surgeon reached for the device and immediately noticed it was hot.Since the device was on the patient the surgeon checked the patient and noticed a small burn.The surgeon also burned his hand while reaching for the device.The healthcare professional claimed the handle wasn't turned on while it wasn't in use.The procedure was completed with a backup device.The patient was diagnosed with a level 2 burn and treated with granuflex.

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: 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 w william cannon drive; austin, TX 78735
• MDR Report Key: 6703135
• MDR Text Key: 79678731
• Report Number: 1643264-2017-00398
• Device Sequence Number: 0
• Product Code: NBH
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 08/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 72200616
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/06/2017
• Initial Date FDA Received: 07/11/2017
• Supplement Dates Manufacturer Received: 07/20/2017; 08/03/2017
• Supplement Dates FDA Received: 07/20/2017; 08/04/2017
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 34 YR