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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. WD, MOTOR DRIVE UNIT,ULTRALIGHT W/ SAW, POWERED, AND ACCESSORIES

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SMITH & NEPHEW, INC. WD, MOTOR DRIVE UNIT,ULTRALIGHT W/ SAW, POWERED, AND ACCESSORIES Back to Search Results
Catalog Number 7205971W
Device Problems Overheating of Device (1437); Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/28/2017
Event Type  malfunction  
Manufacturer Narrative
The reported device was not made available to the designated complaint unit for independent evaluation; thus, a visual inspection and functional testing could not be performed. An analysis of the customer provided picture shows possible repair to the cord performed by an unknown third party and no longer conforms to smith & nephew manufacturing specifications. A relationship, if any, between the subject device and the reported event could not be determined. A review of the device history record shows there are no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended. No containment or corrective actions are recommended at this time. The product associated with this event was discarded and will not be returned.
 
Event Description
It was reported that the mdu was not working properly and became excessively hot. No further information is known at this time. Additional information will be relayed upon receipt.
 
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Brand NameWD, MOTOR DRIVE UNIT,ULTRALIGHT W/
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 drive
austin, TX 78735
MDR Report Key6810927
MDR Text Key118140331
Report Number1643264-2017-00484
Device Sequence Number1
Product Code HAB
Combination Product (y/n)N
Reporter Country CodeIN
PMA/PMN Number
EXEMPT
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 10/23/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/22/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number7205971W
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/13/2017
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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