ANTEVERSION OSTEOTOME SM 200231000

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-04-29 for ANTEVERSION OSTEOTOME SM 200231000 manufactured by Depuy Orthopaedics, Inc. 1818910.

Event Text Entries

[144280763] (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


[144280764] 2 small box chisels 200231000 belonging to consignment kits have been damaged and require replacement. Instruments are intact but bent. Patient status/ outcome / consequences: no. Patient consequence description/was there a clinical outcome experienced by the patient (infection, inflammation, etc. )? No.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1818910-2019-91901
MDR Report Key8562099
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2019-04-29
Date of Report2019-04-09
Date of Event2019-01-01
Date Mfgr Received2019-06-07
Date Added to Maude2019-04-29
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 ContactMS. KARA DITTY-BOVARD
Manufacturer Street1210 WARD AVENUE
Manufacturer CityWEST CHESTER IN 193800988
Manufacturer CountryUS
Manufacturer Postal193800988
Manufacturer Phone6103142063
Manufacturer G1DEPUY ORTHOPAEDICS, INC. 1818910
Manufacturer Street700 ORTHOPAEDIC DRIVE
Manufacturer CityWARSAW IN 465820988
Manufacturer CountryUS
Manufacturer Postal Code465820988
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameANTEVERSION OSTEOTOME SM
Generic NameHIP INSTRUMENTS : CUTTING INSTRUMENTS
Product CodeHWM
Date Received2019-04-29
Catalog Number200231000
Lot NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerDEPUY ORTHOPAEDICS, INC. 1818910
Manufacturer Address700 ORTHOPAEDIC DRIVE WARSAW IN 465820988 US 465820988


Patients

Patient NumberTreatmentOutcomeDate
10 2019-04-29

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