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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
Model Number 72200616S
Device Problems Overheating of Device (1437); Smoking (1585)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  Malfunction  
Event Description

It was reported that mdu gets very hot and smokes. No patient injury was reported.

 
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. 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.

 
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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 west william cannon drive
austin, TX 78735
MDR Report Key7161290
MDR Text Key96453590
Report Number1643264-2018-00012
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 COMPANY REPRESENTATIVE,USER F
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/23/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/03/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number72200616S
Device Catalogue Number72200616S
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer01/09/2018
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/22/2018
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 Reuse

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