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

Catalog Number 72200617S

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/05/2017

Event Type  malfunction  

Event Description

Shorting out.No patient injury or complications were reported.

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 91000516 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
• 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 gonzalez ; 7000 w. william cannon drive; austin, TX 78735
• MDR Report Key: 6613246
• MDR Text Key: 76761268
• Report Number: 1643264-2017-00313
• Device Sequence Number: 1
• Product Code: HAB
• 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: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/27/2017

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
• Device Operator: Health Professional
• Device Catalogue Number: 72200617S
• Device Lot Number: AAM4369
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/17/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/10/2017
• Initial Date FDA Received: 06/05/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/27/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/07/2015
• 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