ATTUNE FEMORAL INTRODUCER 2544-01-005 254401005

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 2020-03-05 for ATTUNE FEMORAL INTRODUCER 2544-01-005 254401005 manufactured by Depuy Ireland - 9616671.

Event Text Entries

[182385331] 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. Investigation summary: examination of the returned device confirmed the reported breakage. The investigation did not indicate that a broader investigation or corrective action was necessary. Depuy synthes considers the investigation closed at this time. Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.
Patient Sequence No: 1, Text Type: N, H10


[182385332] Red handle broke.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1818910-2020-06948
MDR Report Key9793919
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-03-05
Date of Report2020-02-20
Date of Event2020-02-20
Date Mfgr Received2020-03-15
Device Manufacturer Date2013-06-20
Date Added to Maude2020-03-05
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 Street700 ORTHOPAEDIC DR.
Manufacturer CityWARSAW IN 465810988
Manufacturer CountryUS
Manufacturer Postal465810988
Manufacturer Phone6107428552
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 FEMORAL INTRODUCER
Generic NameATTUNE INSTRUMENTS : INSERTION DEVICES
Product CodeHWR
Date Received2020-03-05
Returned To Mfg2020-02-25
Model Number2544-01-005
Catalog Number254401005
Lot NumberABB24912
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerDEPUY IRELAND - 9616671
Manufacturer AddressLOUGHBEG RINGASKIDDY CO. CORK EI


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-05

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