MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SVC REPL, MDU, NON-HAND CNTL, ELITE; SAW, POWERED, AND ACCESSORIES

Model Number	72200617S
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/13/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the mdu gets hot.No patient injury reported.
Additional Manufacturer Narrative
A visual inspection was performed on the exterior of product and no physical damage was observed.Mdu failed functional tests with motor stall error and overheating when power cord was bent near strain relief.Power cord assembly grew warm during testing.After troubleshooting, the cause of motor stall and overheating was observed to be a defective power cord assembly.The power cord's external covering had no visible physical damage.It was determined that the power cord has shorted or open internal wiring.Motor and hall board were tested and passed functional testing.The complaint investigation has concluded that this unit has succumbed to physical damage to the power cord.Factors which can contribute to a shorted power cord include rolling a heavy cart over the cord or excessive bending of the cord.A review of the device history records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.: device returned for evaluation: device evaluated by the manufacturer: evaluation codes updated.

• Brand Name: SVC REPL, MDU, NON-HAND CNTL, ELITE
• Common Device Name: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107 6512
• MDR Report Key: 7034838
• Report Number: 1643264-2017-01730
• Device Sequence Number: 19064104
• Product Code: HAB
• UDI-Device Identifier: 03596010578884
• UDI-Public: (01)03596010578884
• Combination Product (Y/N): N
• Initial Reporter State: MT
• 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): 12/04/2017

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: 72200617S
• Device Catalogue Number: 72200617S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2017
• Initial Date Received by Manufacturer: 11/13/2017
• Supplement Date Received by Manufacturer: 12/01/2017
• Initial Report FDA Received Date: 11/15/2017
• Supplement Report FDA Received Date: 12/04/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1