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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
Model Number 72200873
Device Problem Insufficient Information (3190)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/12/2020
Event Type  malfunction  
Event Description
It was reported that during a knee arthroscopy, the dll controller's prongs were broken. The procedure was completed with a significant delay. Although no backup device is reported, there is no information that reasonably suggests a procedure cancellation, change in surgical technique nor use of competitor device occurred. No patient injury or other complications were reported. All available information has been disclosed. If additional information should become available, a supplemental report will be submitted accordingly.
 
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Brand NameDII CONTROLLER
Type of DeviceARTHROSCOPE
Manufacturer (Section D)
SMITH & NEPHEW, INC.
76 s. meridian ave.
oklahoma city OK 73107 6512
Manufacturer (Section G)
SMITH & NEPHEW, INC.
76 s. meridian ave.
oklahoma city OK 73107 6512
Manufacturer Contact
holly topping
7000 west william cannon drive
austin, TX 78735
5123913905
MDR Report Key9925548
MDR Text Key186613785
Report Number1643264-2020-00194
Device Sequence Number1
Product Code HRX
UDI-Device Identifier03596010607409
UDI-Public03596010607409
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K062850
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 05/05/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/03/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number72200873
Device Catalogue Number72200873
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/25/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/29/2020
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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