ANGLED ACET INSERTR 9200-10-029 920010029

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 2020-03-04 for ANGLED ACET INSERTR 9200-10-029 920010029 manufactured by Depuy International Ltd - 8010379.

Event Text Entries

[182003945] 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


[182003946] It was reported that the offset impactor had a cracked plastic handle. Broach handle was not locking on the broaches. No surgical delay.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1818910-2020-06824
MDR Report Key9787541
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-03-04
Date of Report2020-02-18
Date of Event2020-02-18
Date Mfgr Received2020-04-01
Device Manufacturer Date2018-02-01
Date Added to Maude2020-03-04
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 NameANGLED ACET INSERTR
Generic NameHIP INSTRUMENTS : INSERTION DEVICES
Product CodeHWR
Date Received2020-03-04
Returned To Mfg2020-02-25
Model Number9200-10-029
Catalog Number920010029
Lot NumberMJ3581601
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerDEPUY INTERNATIONAL LTD - 8010379
Manufacturer AddressST. ANTHONY'S ROAD LEEDS LS118DT UK LS11 8DT


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-04

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