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

Catalog Number 72200616

Device Problems Smoking (1585); Sparking (2595)

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

Event Date 05/02/2017

Event Type  malfunction  

Event Description

It was reported that during the knee arthroscopy procedure, the device was smoking a sparking.No reported patient injuries.No other complications were noted.

Manufacturer Narrative

Unit was powered on using the appropriate test equipment and it failed with "short circuit detected" error message and alarm.A small kink was observed in the middle of the power cord.After troubleshooting, the cause of error was observed to be a defective power cord assembly.The complaint investigation determined that the power cord has a shorted or open internal wire.Motor and hall board were tested and passed functional testing.Factors, unrelated to the manufacturing and design of the device which could have contributed to the reported event, include normal wear and tear, causing damage as a result of consistent use over time such as excessive tensile stress applied to the power cord, which could have partially broken one or more signal wires.After the evaluation the root cause for the reported issue was determined to be electrical component failure.A review of the device history record was performed which confirmed no inconsistencies.There are no indications that would suggest that the device did not meet product specifications 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; austin, TX 78735
• MDR Report Key: 6590205
• MDR Text Key: 76039048
• Report Number: 1643264-2017-00284
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 06/05/2017

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: 05/05/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/02/2017
• Initial Date FDA Received: 05/25/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/05/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/24/2015
• 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