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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 Problems Break (1069); Temperature Problem (3022)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/13/2018
Event Type  malfunction  
Event Description
It was reported that the power cord of the device was damaged, the power cord become hot during the test indicating a internal short circuit.This material will be not returned for repair our evaluation, because will be repaired to the technical assistance (b)(6).
 
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.
 
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Brand Name
MOTOR DRIVE UNIT, HAND CNTRL, PWRMX EL
Type of Device
SAW, 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
5123585706
MDR Report Key7923434
MDR Text Key122314054
Report Number1643264-2018-00749
Device Sequence Number1
Product Code HAB
Combination Product (y/n)N
Reporter Country CodeBR
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 11/13/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/01/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number72200616
Was Device Available for Evaluation? No
Date Manufacturer Received11/08/2018
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 Unknown
Patient Sequence Number1
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