ACCURIS TIBIAL INSERT HANDLE 71236012

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-02-17 for ACCURIS TIBIAL INSERT HANDLE 71236012 manufactured by Smith & Nephew, Inc..

Event Text Entries

[182350106] It was reported that during the procedure the item broke inside of the patient. Surgery was not delayed and it is not known if there was an s and n backup device available.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1020279-2020-00572
MDR Report Key9717445
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-02-17
Date of Report2020-04-03
Date of Event2020-01-15
Date Mfgr Received2020-04-02
Device Manufacturer Date2013-01-17
Date Added to Maude2020-02-17
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 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 NameACCURIS TIBIAL INSERT HANDLE
Generic NamePROSTHSIS, KNE, FEMOROTIBIAL, NON-CONSTRAIND, CMNTD, METAL/POLYMR
Product CodeHSX
Date Received2020-02-17
Model Number71236012
Catalog Number71236012
Lot Number13AM10025
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeDA
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 2020-02-17

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