ATTUNE PATELLA DRILL CLAMP 2545-01-055 254501055

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 2020-01-02 for ATTUNE PATELLA DRILL CLAMP 2545-01-055 254501055 manufactured by Depuy Ireland - 9616671.

Event Text Entries

[188632126] Product complaint # (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


[188632127] It was reported that the patella clamp won? T open and close. All pieces were retrieved. No surgical delay.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1818910-2020-00105
MDR Report Key9538797
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-01-02
Date of Report2019-12-09
Date of Event2019-12-09
Date Mfgr Received2020-01-28
Device Manufacturer Date2015-11-12
Date Added to Maude2020-01-02
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 ContactKARA DITTY-BOVARD
Manufacturer Street1210 WARD AVENUE
Manufacturer CityWEST CHESTER IN 465810988
Manufacturer CountryUS
Manufacturer Postal465810988
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 Received2020-01-02
Model Number2545-01-055
Catalog Number254501055
Lot NumberNW169783
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 2020-01-02

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