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

Catalog Number	72200617S
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/05/2017
Type of Reportable Event	Malfunction
Event or Problem Description
Shorting out.No patient injury or complications were reported.
Additional Manufacturer Narrative
The reported complaint of shorting out could not be reproduced but overheating has been confirmed.Unit's housing heats up and motor stalls giving a motor stall error during functional testing.The cable assembly was removed and unit's housing was observed to be corroded internally.The motor/gearbox assembly part number could not be removed from the housing for further assessment due to corrosion.The root cause of this event was identified to be associated with corrosion of the motor and gearbox assembly.A motor stall condition will result in increased current draw from the control unit which will heat the motor and hand piece housing.Factors which can contribute to gearbox corrosion include cleaning and sterilization methods and the chemicals involved.A review of the device history record was performed which confirmed no inconsistencies.

• 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: 6610225
• Report Number: 1643264-2017-00309
• Device Sequence Number: 760485
• Product Code: HAB
• UDI-Device Identifier: 03596010578884
• UDI-Public: (01)03596010578884
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 06/12/2017

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 Catalogue Number: 72200617S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 05/10/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/03/2017
• Supplement Report FDA Received Date: 06/12/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1