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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. MOTOR DRIVE UNIT, HAND CNTRL, PWRMX EL SAW, POWERED, AND ACCESSORIES

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SMITH & NEPHEW, INC. MOTOR DRIVE UNIT, HAND CNTRL, PWRMX EL SAW, POWERED, AND ACCESSORIES Back to Search Results
Catalog Number 72200616
Device Problem Overheating of Device (1437)
Patient Problem Partial thickness (Second Degree) Burn (2694)
Event Date 07/06/2016
Event Type  Injury  
Manufacturer Narrative

(b)(6). No evaluation conducted to date, awaiting receipt of device. (b)(4).

 
Event Description

It was reported that during an arthroscopic procedure, the device overheated and the patient suffered from a second-degree burn. A backup device was utilized to complete the procedure. The patient was reported to be doing well.

 
Manufacturer Narrative

A visual inspection identified that the soak cap lanyard is broken and soak cap is missing. The device housing was also noted to have scratches. Motor/gearbox assembly runs rough due to internal corrosion and could become jammed, causing overheating of hand piece. A cut was found in the insulation of a motor phase wire and was intermittently shorting out to the motor housing. The root cause of this event was identified to be associated with corrosion of the motor and gearbox assembly. A motor stall condition may 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.

 
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Brand NameMOTOR DRIVE UNIT, HAND CNTRL, PWRMX EL
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
james gonzales
150 minuteman road
andover, MA 01810
5123585706
MDR Report Key5826991
MDR Text Key50585787
Report Number1643264-2016-00136
Device Sequence Number1
Product Code HAB
Combination Product (Y/N)N
Reporter Country CodeGM
PMA/PMN NumberEXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/06/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/27/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number72200616
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/07/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/05/2014
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient TREATMENT DATA
Date Received: 07/27/2016 Patient Sequence Number: 1
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