MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SVC REPL,MDU, HAND CNTRL, PWRMX; SAW, POWERED, AND ACCESSORIES

Catalog Number 72200616S

Device Problems Overheating of Device (1437); Smoking (1585)

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

Event Date 04/10/2017

Event Type  malfunction  

Event Description

It was reported that during the procedure the device was smoking and the cable was extremely hot.No patient or user injury was reported.This resulted in a 0-30 minute delay.A backup device was available to complete the procedure.

Manufacturer Narrative

A service replacement powermax elite motor drive unit, part number 72200616s was received on april 28, 2017 and confirmed to be serial number (b)(4).Unit was powered on using the appropriate test equipment and failed with a "short circuit detected" error message and corresponding alarm.A kink was observed in the middle of the power cord.After troubleshooting, the cause of malfunction was observed to be a defective power cord assembly.It was determined that the power cord has a shorted or open internal wire.Motor and hall board were tested and passed functional testing.The complaint was verified and the investigation has concluded that this unit has succumbed to physical damage to power cord assembly.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.Overheating is most likely associated with the short circuit in the power cord which can result in additional current delivery from the control unit and thus generate heat.A review of the manufacturing records shows that this unit was released to distribution on (b)(6) 2014.There are no indications to suggest that the product did not meet manufacturing specification when released to distribution.No containment or corrective actions are recommended at this time.

• Brand Name: SVC REPL,MDU, HAND CNTRL, PWRMX
• 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: james gonzales ; 7000 w. william cannon drive; austin, TX 78735
• MDR Report Key: 6535755
• MDR Text Key: 74260852
• Report Number: 1643264-2017-00242
• 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,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/17/2017

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: 72200616S
• Device Lot Number: AAL68433
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/10/2017
• Initial Date FDA Received: 05/01/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/17/2017
• 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: Reuse
• Patient Sequence Number: 1