K-WIRE 10/10 - LENGTH 100 MM * 115100

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2006-09-28 for K-WIRE 10/10 - LENGTH 100 MM * 115100 manufactured by Newdeal S.a..

Event Text Entries

[514664] The physician reported that total of three (3) incidents had occurred at the user facility where the 100mm k-wires broke off in the bone. In this inquiry, the physician is referencing only two (2) incidents. The physician recounts that the device splits into two (2) pieces, leaving a piece about 12mm long inside the bone that has to be removed. The physician uses additional instruments to remove the remaining k-wire out of the bone tissue.
Patient Sequence No: 1, Text Type: D, B5


[7832841] The product return is not expected. An investigation has been initiated based upon the reported information.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number9615741-2006-00027
MDR Report Key766914
Report Source05,06
Date Received2006-09-28
Date of Report2006-09-26
Date Mfgr Received2006-09-04
Date Added to Maude2006-10-06
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 Location0
Manufacturer ContactDANIEL-GARY 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 100 MM
Generic NameK-WIRE
Product CodeDZK
Date Received2006-09-28
Model Number*
Catalog Number115100
Lot Number*
ID Number*
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Implant FlagY
Date Removed*
Device Sequence No1
Device Event Key754812
ManufacturerNEWDEAL S.A.
Manufacturer Address* LYON FR


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2006-09-28

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