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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SVCE REPL MDU CNTRL PWRMX ELITE SAW, POWERED, AND ACCESSORIES

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SMITH & NEPHEW, INC. SVCE REPL MDU CNTRL PWRMX ELITE SAW, POWERED, AND ACCESSORIES Back to Search Results
Catalog Number 72200616SR
Device Problem Failure to Shut Off (2939)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/02/2018
Event Type  Malfunction  
Event Description

It was reported that device will not shut off. No patient or user injuries were reported. A backup device was available to complete the procedure with no delay.

 
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.

 
Manufacturer Narrative

The device was received for evaluation. A visual inspection was performed on the product and no issue was observed. There was a relationship found between the returned device and the reported incident. Product failed functional testing with motor stall error and overheating. Cause of overheating and errors is a corroded motor/gearbox. The motor/gearbox assembly could not be removed from the housing for further assessment due to corrosion. The complaint was confirmed and the root cause has been determined to be 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.

 
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Brand NameSVCE REPL MDU CNTRL PWRMX ELITE
Type of DeviceSAW, 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 Key7312364
MDR Text Key101616157
Report Number1643264-2018-00194
Device Sequence Number1
Product Code HAB
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberEXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,USER FACI
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup,Followup
Report Date 04/24/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/04/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number72200616SR
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer04/13/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/18/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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