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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SVC REPL,MDU, HAND CNTRL, PWRMX SAW, POWERED, AND ACCESSORIES

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SMITH & NEPHEW, INC. SVC REPL,MDU, HAND CNTRL, PWRMX SAW, POWERED, AND ACCESSORIES Back to Search Results
Catalog Number 72200616S
Device Problems Fluid Leak (1250); Overheating of Device (1437); Noise, Audible (3273)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/08/2017
Event Type  malfunction  
Manufacturer Narrative
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 motor stall error and overheating. Cause of overheating and errors is a corroded motor/gearbox. The motor/gearbox assembly was removed from the housing and the gearbox was removed from the motor. The gearbox was found to be jammed. The motor passed functional testing. The complaint was confirmed and the root cause has been determined to be corrosion of the gearbox assembly. A motor stall condition will 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. It is possible excessive side-loading on the blade can cause it to come into contact with the guide, which can result in the production of a black metallic substance. 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.
 
Manufacturer Narrative
Smith & nephew is submitting this report pursuant to the provisions of 21 c. F. R. Part 803. This report may be based upon information which smith & nephew has not been able to investigate or verify prior to the required reporting date.
 
Event Description
It was reported the powermax elite mdu hand control made a loud noise, became hot and leaked fluid. A back up device was utilized to complete the procedure. No patient injury or complications were reported.
 
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Brand NameSVC REPL,MDU, HAND CNTRL, PWRMX
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 Key6878442
MDR Text Key139546436
Report Number1643264-2017-00560
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 11/27/2017
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 Number72200616S
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/19/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/08/2017
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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