K-WIRE 10/10 LENGTH 70 MM 115070 115070ND

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2007-12-14 for K-WIRE 10/10 LENGTH 70 MM 115070 115070ND manufactured by Newdeal S.a..

Event Text Entries

[768960] The integra sales representative ("representative') reported on behalf of the user facility the following incident: the physician had to perform a revision surgery on a patient to remove a broken device. The device was between the metatarsal and the skin. The original surgery was an insertion of a bold screw. The physician had missed the piece of the device on the post operative x-ray. The user facility is conducting an internal investigation, and the device is not available for return. According to the representative, the physician discussed the procedure, and the physician seemed to follow the surgical technique guide.
Patient Sequence No: 1, Text Type: D, B5


[8037113] The device is not expected to be returned for evaluation. An investigation has been initiated based upon the reported information.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number9615741-2007-00076
MDR Report Key964284
Report Source05,06,07
Date Received2007-12-14
Date of Report2007-12-14
Date Mfgr Received2007-11-15
Date Added to Maude2007-12-19
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactDANIEL HOLDERMAN
Manufacturer Street311 ENTERPRISE DRIVE
Manufacturer CityPLAINSBORO NJ 08536
Manufacturer CountryUS
Manufacturer Postal08536
Manufacturer Phone6099362469
Manufacturer G1NEWDEAL S.A.
Manufacturer Street10, PLACE D'HELVETIE
Manufacturer CityLYON 69006
Manufacturer CountryFR
Manufacturer Postal Code69006
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameK-WIRE 10/10 LENGTH 70 MM
Generic NameK-WIRE
Product CodeDZK
Date Received2007-12-14
Model Number115070
Catalog Number115070ND
Lot NumberE3QY
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Implant FlagN
Date RemovedB
Device Sequence No1
Device Event Key935771
ManufacturerNEWDEAL S.A.
Manufacturer AddressLYON FR


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2007-12-14

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