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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TBD ARTHROSCOPE

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SMITH & NEPHEW, INC. TBD ARTHROSCOPE Back to Search Results
Catalog Number UNKNOWN
Device Problem Insufficient Information (3190)
Patient Problem Injury (2348)
Event Type  Injury  
Event Description
It was reported that a synovectomy on the right thumb was performed by using a vulcan radio-frequency ablation probe to treat mcpj volar plate instability. The patient had its thumb hyperextensibility resolved. However, it was complicated with rupture of the fpl tendon. The patient complained of inability to flex the thumb interphalangeal joint while trying to catch an object at 23 days after the operation. Flexor tendon repair was performed under general anesthesia. The mcpj remained stable and was held by the fibrotic volar plate. The operation technique was modified with a1 pulley release and fpl protection. This patient demonstrated a good hand function in subsequent follow up and she had the mcpj stability maintained at the 11th year after the operation. All available information has been disclosed. If additional information should become available, a supplemental report will be submitted accordingly.
 
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Brand NameTBD
Type of DeviceARTHROSCOPE
Manufacturer (Section D)
SMITH & NEPHEW, INC.
150 minuteman road
andover MA 01810
Manufacturer (Section G)
SMITH & NEPHEW, INC.
150 minuteman road
andover MA 01810
Manufacturer Contact
holly topping
7000 west william cannon drive
austin, TX 78735
5123913905
MDR Report Key9894743
MDR Text Key186538469
Report Number3003604053-2020-00021
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeHK
PMA/PMN Number
K003893
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,literature,other,user
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 05/10/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/28/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/05/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 03/28/2020 Patient Sequence Number: 1
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