ATTUNE PATELLA DRILL CLAMP 254501041

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2019-10-25 for ATTUNE PATELLA DRILL CLAMP 254501041 manufactured by Depuy Ireland - 9616671.

MAUDE Entry Details

Report Number1818910-2019-112072
MDR Report Key9239032
Report SourceCOMPANY REPRESENTATIVE
Date Received2019-10-25
Date of Report2018-11-28
Date Mfgr Received2019-10-29
Device Manufacturer Date2014-03-07
Date Added to Maude2019-10-25
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 ContactMS. KARA DITTY-BOVARD
Manufacturer Street1210 WARD AVENUE
Manufacturer CityWEST CHESTER IN 193800988
Manufacturer CountryUS
Manufacturer Postal193800988
Manufacturer Phone6103142063
Manufacturer G1DEPUY ORTHOPAEDICS, INC. 1818910
Manufacturer Street700 ORTHOPAEDIC DR.
Manufacturer CityWARSAW IN 465810988
Manufacturer CountryUS
Manufacturer Postal Code465810988
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameATTUNE PATELLA DRILL CLAMP
Generic NameATTUNE INSTRUMENTS : PATELLA HANDLE/CLAMPS
Product CodeHXD
Date Received2019-10-25
Catalog Number254501041
Lot NumberNW146257
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerDEPUY IRELAND - 9616671
Manufacturer AddressLOUGHBEG RINGASKIDDY CO. CORK EI


Patients

Patient NumberTreatmentOutcomeDate
10 2019-10-25

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