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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 Known Impact Or Consequence To Patient (2692)
Event Date 02/26/2018
Event Type  malfunction  
Event Description
It was reported that one of the buttons is sticking. No patient injury reported.
 
Manufacturer Narrative
The device was received for evaluation. There was no relationship found between the returned device and the reported incident. A visual inspection was performed on the product and no issue was observed. Complaint of sticking buttons could not be reproduced. Product passed functional and high speed testing (100-10,000 rpms) for 5 minutes each in forward, reverse and oscillate directions. Unit passed functional tests on the dyonics power, dii and dii eip test control units with and without footswitch. Current draw was average for this product and all 3 buttons perform as expected. The complaint was not confirmed and the root cause could not be determined since the reported malfunction could not be duplicated during the product evaluation process.
 
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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 west william cannon drive
austin, TX 
MDR Report Key7361644
MDR Text Key103413981
Report Number1643264-2018-00241
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,Followup
Report Date 04/25/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/22/2018
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 Manufacturer03/16/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/18/2018
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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