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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. RFB, DYONICS POWER WIRE DRIVER SAW, POWERED, AND ACCESSORIES

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SMITH & NEPHEW, INC. RFB, DYONICS POWER WIRE DRIVER SAW, POWERED, AND ACCESSORIES Back to Search Results
Catalog Number 7205789F
Device Problem Smoking (1585)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/09/2017
Event Type  Malfunction  
Event Description

It was reported that the dyonics power unit started smoking when shaver handpiece initiated. It was repeated with a new unit and the same issue outcome. It was kept the same shaver blade. No patient injury reported.

 
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Brand NameRFB, DYONICS POWER WIRE DRIVER
Type of DeviceSAW, POWERED, AND ACCESSORIES
Manufacturer (Section D)
SMITH & NEPHEW, INC.
150 minuteman road
andover MA 01810
Manufacturer (Section G)
SMITH & NEPHEW, INC.
150 minuteman road
andover MA 01810
Manufacturer Contact
jim gonzales
7000 west william cannon drive
austin, TX 78735
MDR Report Key7024996
MDR Text Key92529758
Report Number3003604053-2017-00324
Device Sequence Number1
Product Code HAB
Combination Product (Y/N)N
Reporter Country CodeUK
PMA/PMN NumberEXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 01/04/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received11/13/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number7205789F
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer12/04/2017
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/02/2018
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 Unkown

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