INTERNAL SCREWDRIVER * 119840

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06 report with the FDA on 2005-05-25 for INTERNAL SCREWDRIVER * 119840 manufactured by Newdeal S.a..

Event Text Entries

[398737] The product was delivered for a surgery on 4/2005. It was reported that the internal screwdriver was delivered broken. However the surgeon did not realize it until after trying to set up two implants without success. Another screwdriver was delivered in urgency and the surgeon used it to complete the surgery. The surgery was delayed about two hours.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9615741-2005-00016
MDR Report Key611124
Report Source01,06
Date Received2005-05-25
Date of Report2005-05-24
Date Mfgr Received2005-04-25
Date Added to Maude2005-06-08
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 ContactYANPING WANG
Manufacturer Street311C ENTERPRICE DRIVE
Manufacturer CityPLAINSBORO NJ 08536
Manufacturer CountryUS
Manufacturer Postal08536
Manufacturer Phone6099362322
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 NameINTERNAL SCREWDRIVER
Generic NameKALIX ASSOCIATED IMPLANT INSTRUMENTS
Product CodeKXX
Date Received2005-05-25
Model Number*
Catalog Number119840
Lot NumberD1T9
ID Number*
OperatorHEALTH PROFESSIONAL
Device Availability*
Device Eval'ed by MfgrY
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key600919
ManufacturerNEWDEAL S.A.
Manufacturer Address* LYON FR
Baseline Brand NameINTERNAL SCREWDRIVER
Baseline Generic NameKALIX IMPLANT ASSOCIATED INSTRUMENTS
Baseline Model No*
Baseline Catalog No119840
Baseline ID*


Patients

Patient NumberTreatmentOutcomeDate
10 2005-05-25

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