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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. DII CONTROLLER; ARTHROSCOPE
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SMITH & NEPHEW, INC. DII CONTROLLER; ARTHROSCOPE Back to Search Results
Catalog Number 72200873
Device Problems Overheating of Device (1437); Electrical Shorting (2926)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/04/2023
Event Type  malfunction  
Manufacturer Narrative
Internal complaint reference:(b)(4).
 
Event Description
It was reported that during set up for a knee arthroscopy, the dyonics ii controller had a shortage issue which result of an overheated device.There was a smith and nephew back up device available and no surgical delay was reported.There was no patient involvement.
 
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Brand Name
DII CONTROLLER
Type of Device
ARTHROSCOPE
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 Key18587954
MDR Text Key334050274
Report Number1643264-2024-00066
Device Sequence Number1
Product Code HRX
UDI-Device Identifier03596010607409
UDI-Public03596010607409
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K062849
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 02/14/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/26/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number72200873
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/04/2024
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/12/2024
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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