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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
Model Number 72201500
Device Problem Connection Problem (2900)
Patient Problem No Patient Involvement (2645)
Event Date 06/26/2020
Event Type  Malfunction  
Event Description

It was reported that during the set up before the surgery the dyonics powermini was giving an error message and the handpiece was not recognized. No patient injuries or delay reported. Smith and nephew back-up was available to complete the surgery. All available information has been disclosed. If additional information should become available, a supplemental report will be submitted accordingly.

 
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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
Manufacturer (Section G)
SMITH & NEPHEW, INC.
76 s. meridian ave.
oklahoma city OK 73107
Manufacturer Contact
holly topping
7000 west william cannon drive
austin, TX 78735
5123913905
MDR Report Key10425843
MDR Text Key203506840
Report Number1643264-2020-00884
Device Sequence Number1
Product Code HAB
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberEXEMPT
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 08/25/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/19/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number72201500
Device Catalogue Number72201500
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer07/22/2020
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/24/2020
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 Unkown

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