GII PS HI FLEX ISRT TR S1-2 9 71430401

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-02-11 for GII PS HI FLEX ISRT TR S1-2 9 71430401 manufactured by Smith & Nephew, Inc..

Event Text Entries

[178969475] It was reported that during a tka procedure, the trial insert cracked in half while inserting. No injuries or delays reported. A backup device was available.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1020279-2020-00514
MDR Report Key9697069
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-02-11
Date of Report2020-02-11
Date of Event2020-01-29
Date Mfgr Received2020-01-29
Date Added to Maude2020-02-11
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 PS HI FLEX ISRT TR S1-2 9
Generic NameTRAY, SURGICAL, INSTRUMENT
Product CodeFSM
Date Received2020-02-11
Model Number71430401
Catalog Number71430401
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 2020-02-11

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