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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. DYONICS POWERMINI, WITH HAND CONTROLS SAW, POWERED, AND ACCESSORIES

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SMITH & NEPHEW, INC. DYONICS POWERMINI, WITH HAND CONTROLS SAW, POWERED, AND ACCESSORIES Back to Search Results
Catalog Number 72201500
Device Problem Overheating of Device (1437)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/22/2017
Event Type  malfunction  
Event Description
It was reported that before the procedure, during set-up, the device overheated. No reported patient injuries. No other complications were noted.
 
Manufacturer Narrative
Complaint of overheating could not be confirmed. Product passed functional testing (100-5,000 rpms) for 10 minutes. Unit passed functional tests on both dii and dii eip test control units with and without footswitch. Mdu did not overheat or lock up while using three different type blades during functional testing. All functions performed as expected. After the evaluation the root cause for the reported issue was determined to be that there was no problem found. A review of the device history record was performed which confirmed no inconsistencies. There are no indications that would suggest that the device did not meet product specifications upon release into distribution.
 
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Brand NameDYONICS POWERMINI, WITH HAND CONTROLS
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
austin, TX 78735
MDR Report Key6527086
MDR Text Key74019584
Report Number1643264-2017-00226
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 05/08/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/27/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number72201500
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/12/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/02/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/11/2016
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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