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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 Leak/Splash (1354)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/20/2021
Event Type  Injury  
Manufacturer Narrative
Internal complaint reference case-(b)(4).
 
Event Description
It was reported that during a wrist joint surgery using the dyonics powermini, with hand controls, liquid like black sludge emerged from the tip of the blade. When the blade was removed from the wand the black liquid remained on the wand and entered into the patient's body. It is unknown if there was a delay or if a backup device was available and how the issue was resolved. It is unknown how the event was treated and the outcome of the patient. 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 Key11304598
MDR Text Key231155975
Report Number1643264-2021-00524
Device Sequence Number1
Product Code HAB
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/12/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/09/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number72201500
Device Catalogue Number72201500
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/10/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 02/09/2021 Patient Sequence Number: 1
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