MAUDE Adverse Event Report: SMITH & NEPHEW, INC. MOTOR DRIVE UNIT,ULTRALIGHT W/; SAW, POWERED, AND ACCESSORIES

Catalog Number	7205971
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/29/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device was shorting out.There was a backup device available to complete the procedure with no delay.No patient injuries were reported.This is an obsolete product, therefore, the device cannot be exchanged, only returned.
Additional Manufacturer Narrative
The reported device was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.A relationship, if any, between the subject device and the reported event could not be determined.A review of the device history record shows there are no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.If the product associated with this event is returned at a future date, this evaluation will be reopened for investigation.
Additional Manufacturer Narrative
The device was received for evaluation.There was a relationship found between the returned device and the reported incident.A visual inspection was performed on the exterior of product and no physical damage was observed.Mdu failed functional tests with hand piece overload when power cord was bent or twisted.Power cord assembly grew warm during testing.After troubleshooting, the cause of the overheating was observed to be a defective power cord assembly.A visual inspection was performed on the power cords external covering and no physical damage was observed but insulation is discolored from overheating.It was determined that the power cord has shorted and/or opens internal wiring.Motor was tested and passed functional testing.The complaint investigation has concluded that this unit has succumbed to physical damage to 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.

• Brand Name: MOTOR DRIVE UNIT,ULTRALIGHT W/
• 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: 8070166
• Report Number: 1643264-2018-00869
• Device Sequence Number: 14044288
• Product Code: HAB
• UDI-Device Identifier: 03596010445834
• UDI-Public: 03596010445834
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/13/2019

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 Catalogue Number: 7205971
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2019
• Initial Date Received by Manufacturer: 10/30/2018
• Supplement Date Received by Manufacturer: 12/28/2018; 05/08/2019
• Initial Report FDA Received Date: 11/14/2018
• Supplement Report FDA Received Date: 12/31/2018; 05/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1