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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
Model Number 72200616S
Device Problem Overheating of Device (1437)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/12/2017
Event Type  malfunction  
Manufacturer Narrative
The device was received for evaluation. There was a relationship found between the returned device and the reported incident. Corrosion was observed on the cable assembly connection. Product failed functional testing with motor stall error and overheating. Cause of overheating and errors is a corroded motor/gearbox. The motor/gearbox assembly could not be removed from the housing for further assessment due to corrosion. The complaint was confirmed and the root cause has been determined to be corrosion of the motor and 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. 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
No evaluation conducted to date, awaiting receipt of device.
 
Event Description
It was reported that during testing, the mdu was overheating. A backup device was available. No delay or complications were noted. No injuries were noted as a result.
 
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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 dr
austin, TX 78735
MDR Report Key6878271
MDR Text Key117307668
Report Number1643264-2017-00557
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 10/13/2017
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 Model Number72200616S
Device Catalogue Number72200616S
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/26/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/12/2017
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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