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U.S. Department of Health and Human Services

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

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SMITH & NEPHEW, INC. SVCE REPL MDU CNTRL PWRMX ELITE SAW, POWERED, AND ACCESSORIES Back to Search Results
Catalog Number 72200616SR
Device Problem Mechanical Problem (1384)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
The reported device, used in treatment, was received for evaluation. There was a relationship found between the returned device and the reported incident. A visual inspection was performed on the product and observed a discolored cord. A functional evaluation revealed a jammed motor/ blade stall. 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. A complaint history review concluded this was a repeat issue. The complaint was confirmed and the root cause has been associated with a mechanical component failure. Factors that could have contributed to the reported event include corrosion in the gearbox/motor assembly from cleaning and sterilization methods and the chemicals involved over a period of time or one or more of the motor phases shorting out.
 
Event Description
It was reported that during procedure, the motor drive unit cuts out intermittently. The malfunction was solved with no delays or patient harm using a back up device. Results of investigation have concluded that this unit had a blade stall which makes it a reportable event.
 
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Brand NameSVCE REPL MDU CNTRL PWRMX ELITE
Type of DeviceSAW, POWERED, AND ACCESSORIES
Manufacturer (Section D)
SMITH & NEPHEW, INC.
76 s. meridian ave.
oklahoma city OK 73107
Manufacturer (Section G)
SMITH & NEPHEW, INC.
76 s. meridian ave.
oklahoma city OK 73107
Manufacturer Contact
holly topping
7000 west william cannon drive
austin, TX 78735
5123913905
MDR Report Key10817562
MDR Text Key215536067
Report Number1643264-2020-01756
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 Other Health Care Professional
Type of Report Initial
Report Date 11/10/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/10/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number72200616SR
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/24/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/06/2020
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?
Type of Device Usage Unkown

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