GII TIB TRY IMPL IMPACTOR 71440472

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2020-02-19 for GII TIB TRY IMPL IMPACTOR 71440472 manufactured by Smith & Nephew, Inc..

Event Text Entries

[181604943] It was reported that during a tka procedure, a piece of plastic fractured off during impaction. There were no delays in the procedure and no backup device available. No patient injuries were reported.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1020279-2020-00644
MDR Report Key9729836
Report SourceCOMPANY REPRESENTATIVE,USER F
Date Received2020-02-19
Date of Report2020-02-19
Date of Event2020-02-03
Date Mfgr Received2020-02-03
Date Added to Maude2020-02-19
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactDR. SARAH FREESTONE
Manufacturer Street1450 BROOKS ROAD
Manufacturer CityMEMPHIS TN 38116
Manufacturer CountryUS
Manufacturer Postal38116
Manufacturer Phone0447940038
Manufacturer G1SMITH & NEPHEW, INC.
Manufacturer Street1450 BROOKS ROAD
Manufacturer CityMEMPHIS TN 38116
Manufacturer CountryUS
Manufacturer Postal Code38116
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameGII TIB TRY IMPL IMPACTOR
Generic NameTRAY, SURGICAL, INSTRUMENT
Product CodeFSM
Date Received2020-02-19
Model Number71440472
Catalog Number71440472
OperatorHEALTH PROFESSIONAL
Device Availability*
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerSMITH & NEPHEW, INC.
Manufacturer Address1450 BROOKS ROAD MEMPHIS TN 38116 US 38116


Patients

Patient NumberTreatmentOutcomeDate
10 2020-02-19

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.