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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 Smoking (1585)
Patient Problem No Information (3190)
Event Type  malfunction  
Event Description
It was reported that the motor drive unit is smoking.It is unknown whether the malfunction was noticed during a surgical case.Further information is not available.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
 
Manufacturer Narrative
The reported device, intended for use in treatment, 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 issues were observed.A functional evaluation did not reveal any problems.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.The complaint was not verified 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 Name
DYONICS POWERMINI WITH HAND CONTROLS
Type of Device
SAW, POWERED, AND ACCESSORIES
Manufacturer (Section D)
SMITH & NEPHEW, INC.
76 s. meridian ave.
oklahoma city OK 73107 6512
MDR Report Key9226031
MDR Text Key163370598
Report Number1643264-2019-00722
Device Sequence Number1
Product Code HAB
UDI-Device Identifier03596010621696
UDI-Public03596010621696
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Type of Report Initial,Followup
Report Date 11/28/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/23/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number72201500
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/17/2019
Date Manufacturer Received11/27/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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