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 Date 06/21/2017

Event Type  malfunction  

Event Description

It was reported the powermax elite mdu hand control got warm before the procedure.No injuries or complications were reported as a result.

Manufacturer Narrative

Unit was powered on using the appropriate test equipment and it failed functional tests with motor stall error and overheating when power cord was bent at strain relief.Power cord assembly grew warm during testing.After troubleshooting, the cause of error was observed to be a defective power cord assembly.A visual inspection was performed on the power cords external covering and no physical damage was observed, only cosmetic.It was determined that the power cord has a shorted or open internal wire.Motor and hall board were tested and passed functional testing.Mdu is over 2 years old.The complaint investigation has concluded that this unit has succumbed to physical damage to power cord.A review of the device history record shows that this device passed all acceptance criteria and was compliant upon release for distribution.There are no indications to suggest the device did not meet product specifications nor does it allege any product deficiencies upon release into distribution.

• 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: 6673155
• MDR Text Key: 78584612
• Report Number: 1643264-2017-00362
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 07/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2017
• 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: 06/22/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/07/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/05/2014
• 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