ACTIS RETAINING STEM INSERTER 2010-07-100 201007100

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 2020-02-28 for ACTIS RETAINING STEM INSERTER 2010-07-100 201007100 manufactured by Depuy Ireland - 9616671.

Event Text Entries

[184932277] 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


[184932278] It was reported that the instrument threads stripped. No surgical delay.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1818910-2020-06443
MDR Report Key9771530
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-02-28
Date of Report2020-02-13
Date of Event2020-02-13
Date Mfgr Received2020-03-12
Device Manufacturer Date2017-07-21
Date Added to Maude2020-02-28
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 NameACTIS RETAINING STEM INSERTER
Generic NameINSERTION DEVICES
Product CodeKWL
Date Received2020-02-28
Returned To Mfg2020-02-25
Model Number2010-07-100
Catalog Number201007100
Lot NumberABG41173
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 2020-02-28

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