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

Catalog Number 72200616S

Device Problem Overheating of Device (1437)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/12/2017

Event Type  malfunction  

Event Description

It was reported that the mdu cable became very hot during a shoulder scope procedure.A backup mdu was use to complete the procedure.No injuries or complications were noted as a result.

Manufacturer Narrative

Unit was powered on using the appropriate test equipment and it failed with "short circuit detected" error message and alarm.A 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.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 the 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.No containment or corrective actions are recommended at this time.A review of the device history record was performed which confirmed no inconsistencies.

• 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: jim gonzales ; 7000 w william cannon drive; austin, TX 78735
• MDR Report Key: 6598785
• MDR Text Key: 76385089
• Report Number: 1643264-2017-00299
• Device Sequence Number: 1
• Product Code: HAB
• UDI-Device Identifier: 03596010565105
• UDI-Public: (01)03596010565105
• 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: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 06/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 72200616S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/08/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/12/2015
• 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