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

Catalog Number 72200616

Device Problem Overheating of Device (1437)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

A visual inspection was performed on the product and no issue was observed.A functional evaluation revealed that the motor overheated during testing.The complaint has been confirmed and a root cause has been associated with a mechanical component failure.Factors, unrelated to the manufacturing and design of the device which could have contributed to the reported event, include increased current draw due to corrosion in the gearbox/motor assembly from cleaning and sterilization methods and the chemicals involved over a period of time.Manufacturing records show that the device was released into distribution new in march of 2016.(b)(4).

Event Description

It was reported that the dyonics mdu hand control powermax was overheating.It was plugged into the shaver box before the case and the scrub felt it overheating.There were no patient injuries as a result of the event.

• 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
• MDR Report Key: 6559547
• MDR Text Key: 75023398
• Report Number: 1643264-2017-00262
• 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,health
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 05/10/2017

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: 72200616
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/05/2017
• Initial Date FDA Received: 05/11/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/15/2016
• 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