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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 Sticking (1597)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
The device 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 no issue was observed. A functional evaluation revealed a handpiece error and stuck button. The complaint was confirmed and the root cause has been associated with a mechanical component failure. Factors that could have contributed to the event include a buildup of corrosion/debris around the spring from cleaning chemical fluid ingression over time. No containment or corrective actions are recommended at this time. A review of the device history record was performed which confirmed no inconsistencies.
 
Event Description
It was reported that during routine inspections / testing the hand controls on the mdu were sticking which may cause the device to run when not intended. No injuries were reported as a result.
 
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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 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 Key6866615
MDR Text Key86442946
Report Number1643264-2017-00542
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 health professional,user faci
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 09/14/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/14/2017
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 Manufacturer05/24/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/14/2017
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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