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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. MINI MOTOR DRIVE UNIT, EP-1, SAW, POWERED, AND ACCESSORIES

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SMITH & NEPHEW, INC. MINI MOTOR DRIVE UNIT, EP-1, SAW, POWERED, AND ACCESSORIES Back to Search Results
Catalog Number 7205357
Device Problems Overheating of Device (1437); Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/21/2018
Event Type  malfunction  
Event Description
It was reported that motor failed, it got very hot. A backup device was available to complete the procedure with no delay or patient injuries.
 
Manufacturer Narrative
The device was received for evaluation. A visual inspection was performed on the product and no issue was observed. There was a relationship found between the returned device and the reported incident. Product failed functional testing with blade stall error and overheating. Cause of overheating and errors is expected wear and tear on motor and gearbox assembly. The motor/gearbox assembly could not be removed from the housing for further assessment due to the design of the mdu. The motor/gearbox for this type of mini mdu is potted inside of the housing and unit is scrapped when the motor/gearbox jams or wears out. The complaint was confirmed and the root cause has been determined to be expected wear and tear on the motor and gearbox assembly. The complaint investigation has concluded that the device is almost 5 years old and has exceeded its recommended service life limit and has succumbed to expected wear and tear. A motor stall condition will result in increased current draw from the control unit which will heat the motor and hand piece housing. A review of the device history records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.
 
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Brand NameMINI MOTOR DRIVE UNIT, EP-1,
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 west william cannon drive
austin, TX 78735
MDR Report Key7645784
MDR Text Key112719897
Report Number1643264-2018-00505
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,user f
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/24/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/28/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number7205357
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/13/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/21/2018
Was Device Evaluated by Manufacturer? Yes
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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