RASPING STRIKE PLATE 221701516

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 2018-07-23 for RASPING STRIKE PLATE 221701516 manufactured by Depuy Ireland 961610?.

Event Text Entries

[114678110] (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


[114678111] It was reported that the pinnacle tf gription rasping strike plate release button is broken and cannot be removed from the augment rasping handle. There was no surgical delay applicable to this case.
Patient Sequence No: 1, Text Type: D, B5


[118572251] Product complaint #: (b)(4). Investigation summary: examination of the returned instrument confirmed the complaint. Depuy considers the investigation closed at this time. Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary. 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


MAUDE Entry Details

Report Number1818910-2018-64948
MDR Report Key7709829
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2018-07-23
Date of Report2018-06-27
Date of Event2018-06-27
Date Mfgr Received2018-08-01
Device Manufacturer Date2012-05-16
Date Added to Maude2018-07-23
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 ContactMR. CHAD GIBSON
Manufacturer Street700 ORTHOPAEDIC DRIVE
Manufacturer CityWARSAW IN 46582
Manufacturer CountryUS
Manufacturer Postal46582
Manufacturer Phone5743725905
Manufacturer G1DEPUY ORTHOPAEDIC INC, 1818910
Manufacturer Street700 ORTHOPAEDIC DRIVE
Manufacturer CityWARSAW IN 46582
Manufacturer CountryUS
Manufacturer Postal Code46582
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameRASPING STRIKE PLATE
Generic NameGRIPTION TF INSTRUMENTS : IMPACTION INSTRUMENTS
Product CodeHTR
Date Received2018-07-23
Returned To Mfg2018-07-11
Catalog Number221701516
Lot NumberSO2005149
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerDEPUY IRELAND 961610?
Manufacturer AddressLOUGHBEG RINGASKIDDY CORK EI


Patients

Patient NumberTreatmentOutcomeDate
10 2018-07-23

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