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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 08/29/2017
Event Type  malfunction  
Manufacturer Narrative
There was a relationship found between the returned device and the reported incident. A visual inspection revealed no issues. Functional evaluation resulted in hand piece error when inserted into mdu receptacle on test control unit. Root cause has been determined to be corrosion of the reverse button assembly. Factors that could have contributed to the event include a buildup of corrosion/debris around the button assembly from cleaning chemical fluid ingression over time. Device history records review showed that the product meet manufacturing specification, then, it would be able to perform as intended.
 
Event Description
It was reported the powermax elite mdu hand control a speed shift and button sticking issues. No patient injury or complications were reported.
 
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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
MDR Report Key6874410
MDR Text Key139545105
Report Number1643264-2017-00551
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 Received09/18/2017
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 Manufacturer09/06/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/29/2017
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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