TRAY ELITE PRMIUM II SHLDR ARTHRO SYS 72202042

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-28 for TRAY ELITE PRMIUM II SHLDR ARTHRO SYS 72202042 manufactured by Smith & Nephew, Inc..

Event Text Entries

[140437969] (b)(6).
Patient Sequence No: 1, Text Type: N, H10


[140437970] It was reported that the drill broke inside the femoral tunnel. Fragments were totally removed. It is unknown if there was delay or if a back up device was used. Procedure was successfully completed. No patient injury or other complications were reported.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3003604053-2019-00041
MDR Report Key8462388
Date Received2019-03-28
Date of Report2019-05-22
Date of Event2019-03-26
Date Mfgr Received2019-05-21
Device Manufacturer Date2015-01-04
Date Added to Maude2019-03-28
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactJIM GONZALES
Manufacturer Street7000 WEST WILLIAM CANNON DRIVE
Manufacturer CityAUSTIN TX 78735
Manufacturer CountryUS
Manufacturer Postal78735
Manufacturer Phone5123585706
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 Report0

Device Details

Brand NameTRAY ELITE PRMIUM II SHLDR ARTHRO SYS
Generic NameSTERILIZATION WRAP CONTAINERS, TRAYS, CASSETTES & OTHER ACCESSORIES
Product CodeKCT
Date Received2019-03-28
Catalog Number72202042
Lot Number14990002
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
10 2019-03-28

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