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U.S. Department of Health and Human Services

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

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SMITH & NEPHEW, INC. SVC REPL,MDU, HAND CNTRL, PWRMX SAW, POWERED, AND ACCESSORIES Back to Search Results
Catalog Number 72200616S
Device Problems Overheating of Device (1437); Device Stops Intermittently (1599)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/23/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that prior to a procedure the device was overheating and functioning intermittently. A backup device was utilized to complete the procedure. No patient injury or complications were reported.
 
Manufacturer Narrative
Cause of overheating and errors is a corroded motor/gearbox. The motor/gearbox was removed from the housing. The gearbox was removed from motor. The cable assembly and motor passed functional testing. The gearbox was found to be jammed and corroded internally. A review of the manufacturing records shows that this unit was released to distribution on or about may 25, 2012. 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.
 
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Brand NameSVC REPL,MDU, HAND CNTRL, PWRMX
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 dr.
austin, TX 78735
MDR Report Key6468091
MDR Text Key72228750
Report Number1643264-2017-00191
Device Sequence Number1
Product Code HAB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/17/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/06/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number72200616S
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/05/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/09/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/25/2012
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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