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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 No Consequences Or Impact To Patient (2199)
Event Date 08/22/2017
Event Type  malfunction  
Manufacturer Narrative
There was a relationship found between the returned device and the reported incident. A visual inspection was performed on the product and no issue was observed. Product failed functional testing with motor stall error and overheating. Cause of overheating and errors is a corroded motor/gearbox. The gearbox was found to be jammed. The front seal retainer of the motor/gearbox assembly was out of position, allowing fluid ingress that lead to the identified corrosion and subsequent jamming of the bearing/rotor. The complaint was confirmed and the root cause was determined to be a seal failure.
 
Manufacturer Narrative
No evaluation conducted to date, awaiting receipt of device.
 
Event Description
It was reported that during the procedure, the mdu is getting hot and not running. A backup smith and nephew device was available. No injuries or complications were reported.
 
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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
jim gonzales
7000 w william cannon dr
austin, TX 78735
MDR Report Key6878272
MDR Text Key118797677
Report Number1643264-2017-00558
Device Sequence Number1
Product Code HAB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/18/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/20/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number72200616
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 Received12/14/2017
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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