SIGMA HP UNI FB KEEL OSTEOTOME 202447111

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 2019-05-20 for SIGMA HP UNI FB KEEL OSTEOTOME 202447111 manufactured by Depuy Orthopaedics, Inc. 1818910.

Event Text Entries

[145612304] (b)(4). If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10


[145612305] It was reported that the back screw piece was broke off that holds tibia gauge in handle. No surgical delay.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1818910-2019-94086
MDR Report Key8625716
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2019-05-20
Date of Report2019-05-02
Date of Event2019-05-02
Date Mfgr Received2019-06-10
Device Manufacturer Date2014-10-13
Date Added to Maude2019-05-20
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 ContactMS. KARA DITTY-BOVARD
Manufacturer Street1210 WARD AVENUE
Manufacturer CityWEST CHESTER PA 19380XXXX
Manufacturer CountryUS
Manufacturer Postal19380XXXX
Manufacturer Phone6107428552
Manufacturer G1DEPUY ORTHOPAEDICS, INC. 1818910
Manufacturer Street700 ORTHOPAEDIC DRIVE
Manufacturer CityWARSAW IN 465820988
Manufacturer CountryUS
Manufacturer Postal Code465820988
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSIGMA HP UNI FB KEEL OSTEOTOME
Generic NameKNEE INSTRUMENT : CUTTING INSTRUMENTS
Product CodeHWM
Date Received2019-05-20
Returned To Mfg2019-05-15
Catalog Number202447111
Lot NumberGM4214002
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerDEPUY ORTHOPAEDICS, INC. 1818910
Manufacturer Address700 ORTHOPAEDIC DRIVE WARSAW IN 465820988 US 465820988


Patients

Patient NumberTreatmentOutcomeDate
10 2019-05-20

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