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

Model Number 72200616

Device Problem Overheating of Device (1437)

Patient Problems Burn(s) (1757); Full thickness (Third Degree) Burn (2696); Blister (4537)

Event Date 10/06/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that during use in an arthroscopy, the motor drive unit developed enormous heat, the surgeon was no longer able to touch the shaver handpiece or continue operating with it except with compresses.The heat was distributed over the entire handpiece, especially at the transition between cable and handpiece.Also the shaver handpiece shows traces of smoke inside.The next day's follow-up appointment ((b)(6) 2021) - the surgeon informed that the patient had a burn; the handpiece was normally placed at cuff level, but must have slipped down accordingly.The procedure was completed with non-significant delay and was finished with the same device.No patient complications were reported.

Manufacturer Narrative

The reported device was received for evaluation.A visual evaluation revealed the mdu housing was worn from use.A functional evaluation revealed a blade stall error and overheating.It was determined the device contributed to the reported event.The complaint was confirmed, and the root cause was associated with a mechanical component failure.Factors which can contribute to overheating include a blade stall condition that will result in increased current draw from the control unit which will heat the motor and hand piece housing.This can be the result of gearbox corrosion caused by cleaning and sterilization methods and the chemicals involved.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.A complaint history review concluded this was a repeat event.A risk management review found that the reported failure was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.The instructions for use was reviewed and found to include conditions of off label use and technique specifics, as well as precautions and warnings related to the use of the device.Our clinical investigation concluded: this case reports that a third-degree burn was left on the patient¿s left thigh following the use of the motor drive unit.Although requested the photos nor the operative report was provided for review.Based on the limited information provided the root cause could not be definitely concluded.It was communicated via e-mail that the patient is now doing well following treatment of the burn/ blister.Should any additional clinical information be provided this complaint will be re-evaluated.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.No containment or corrective actions are recommended at this time.

Manufacturer Narrative

H2: additional information ¿b5¿.

Event Description

It was reported that during use in an arthroscopy, the motor drive unit developed enormous heat, the surgeon was no longer able to touch the shaver handpiece or continue operating with it except with compresses.The heat was distributed over the entire handpiece, especially at the transition between cable and handpiece.Also the shaver handpiece shows traces of smoke inside.The next day's follow-up appointment (07.10.2021) - the surgeon informed that the patient had a third degree burn on the left thy, ventral with the size of 5cmx3cm that was treated with common wound dressings; the burn blister was opened to take care the wound for about 6 weeks.The handpiece was normally placed at cuff level, but must have slipped down accordingly.The procedure was completed with non-significant delay and was finished with the same device.The patient is doing well now.

• 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
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 12725739
• MDR Text Key: 279251206
• Report Number: 1643264-2021-02385
• Device Sequence Number: 1
• Product Code: HAB
• UDI-Device Identifier: 03596010555472
• UDI-Public: 03596010555472
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Consumer,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2021
• Is this an Adverse Event Report?: Yes
• 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
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/20/2022
• 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
• Patient Outcome(s): Other