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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 Problems Overheating of Device (1437); Key or Button Unresponsive/not Working (4063)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/01/2024
Event Type  malfunction  
Event Description
It was reported that the dyonics powermini had an error, heated up, and the buttons were not working.It is unknown whether the event happened during surgery or if there was patient involvement; however, the procedure was completed without surgical delay using a smith and nephew backup device.No further complications were reported.
 
Manufacturer Narrative
H10: internal complaint reference number: (b)(4).
 
Event Description
It was reported that during set up for an ankle scope, dyonics powermini had an error, heated up, and the buttons were not working.There was a back-up device available and no surgical delay was reported.There was no patient involvement.
 
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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
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 Key19201809
MDR Text Key341292544
Report Number1643264-2024-00287
Device Sequence Number1
Product Code HAB
UDI-Device Identifier03596010621696
UDI-Public03596010621696
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 Health Professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 05/13/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
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 Manufacturer04/18/2024
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 04/09/2024
Initial Date FDA Received04/29/2024
Supplement Dates Manufacturer Received05/08/2024
Supplement Dates FDA Received05/13/2024
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 Unknown
Patient Sequence Number1
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