TBD UNKNOWN

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,literature,other,user report with the FDA on 2020-03-28 for TBD UNKNOWN manufactured by Smith & Nephew, Inc..

Event Text Entries

[186537920] 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.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3003604053-2020-00020
MDR Report Key9894734
Report SourceFOREIGN,LITERATURE,OTHER,USER
Date Received2020-03-28
Date of Report2020-03-28
Date Mfgr Received2020-03-02
Date Added to Maude2020-03-28
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactHOLLY TOPPING
Manufacturer Street7000 WEST WILLIAM CANNON DRIVE
Manufacturer CityAUSTIN TX 78735
Manufacturer CountryUS
Manufacturer Postal78735
Manufacturer Phone5123913905
Manufacturer G1SMITH & NEPHEW, INC.
Manufacturer Street150 MINUTEMAN ROAD
Manufacturer CityANDOVER MA 01810
Manufacturer CountryUS
Manufacturer Postal Code01810
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameTBD
Generic NameARTHROSCOPE
Product CodeHRX
Date Received2020-03-28
Catalog NumberUNKNOWN
Lot NumberUNKNOWN
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerSMITH & NEPHEW, INC.
Manufacturer Address150 MINUTEMAN ROAD ANDOVER MA 01810 US 01810


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2020-03-28

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