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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 left thumb was performed by using a vulcan radio-frequency ablation probe to treat mcpj volar plate instability. However, this case had recurrence of thumb mcpj hyperextension noted at 10 weeks post operation which progressed to 30 degrees of hyperextension at 6 months post op. The patient complained of persistent pain and weakness at the thumb. Therefore, open volar plate capsulodesis with suture anchor was performed at 13 months after the first operation. Patient outcome is unknown. 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 Key9894734
MDR Text Key186537920
Report Number3003604053-2020-00020
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 Received05/08/2020
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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