MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SVCE,MOT DR UNIT, HNDCONT POWERMAX ELITE; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Model Number	72200872S
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the powermax elite mdu hand control turns on by itself.No patient injury or complications were reported.
Additional Manufacturer Narrative
Unit was powered on using the appropriate test equipment and it failed functional testing by turning itself on and off when the power cord was moved or jiggled near the strain relief.A kink was observed near the strain relief located at base of mdu.After troubleshooting, the cause of error 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 investigation has concluded that this unit has succumbed to physical damage to power cord.

• Brand Name: SVCE,MOT DR UNIT, HNDCONT POWERMAX ELITE
• Common Device Name: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107 6512
• MDR Report Key: 6762982
• Report Number: 1643264-2017-00454
• Device Sequence Number: 1412050
• Product Code: HWE
• UDI-Device Identifier: 03596010653703
• UDI-Public: (01)03596010653703
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/23/2017

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
• Operator of Device: Health Professional
• Device Model Number: 72200872S
• Device Catalogue Number: 72200872S
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/31/2017
• Supplement Date Received by Manufacturer: 08/23/2017
• Initial Report FDA Received Date: 08/03/2017
• Supplement Report FDA Received Date: 08/23/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1