BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRANIAL ACCESS KIT W/TWIST LOCK DRILL GUARD

    MDR report key: 569395 · Received January 20, 2005

    Report

    Report Number
    1121308-2005-00003
    Event Type
    Malfunction
    Date Received
    January 20, 2005
    Report Date
    January 19, 2005
    Manufacturer
    INTEGRA LIFESCIENCES CORP.
    Product Code
    HBF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER ORDERS KIT WHICH CONTAINS THE CRANIAL DRILL. OVER THE LAST 3 WEEKS, THERE HAVE BEEN 3 INCIDENTS WITH 3 SEPARATE PTS, THE DRILL BIT IS USED TO CREATE BURR HOLE IN THE PT'S SKULL. AT WHAT APPEARS TO BE THE END OF THE DRILLING PROCEDURE, SOME RESISTANCE IS NOTED AND THE SURGEON PULLS THE DRILL OUT OF THE SKULL AND THE DRILL BIT FALLS OUT OR IS LOOSE. THIS HAS OCCURRED WITH TWO SEPARATE SURGEONS. NO PT INJURY IS REPORTED, ANOTHER KIT HAS BEEN READILY AVAILABLE TO FINISH THE PROCEDURE BUT THIS POSES AS AN INCOVENIENCE TO THE SURGEON. THERE LOT NUMBERS ARE OF THE DRILLS THAT ARE CURRENTLY ON THE CUSTOMER'S SHELF V04142, V04111, K01266 AND W04063. NO RETURNS ARE EXPECTED, THE DRILLS HAVE BEEN DISCARDED. ADD'L INFO WAS RECEIVED ON JAN. 2005. THE SURGEON REPORTED THAT THE DRILL DID NOT BREAK AT THE HANDLE BUT AT THE DRILL BIT. THE DRILL BIT DETACHED FROM THE CRANK APPARATUS, LEAVING A LARGE AND UNSIGHTLY METAL ANTENNA IN THE HEAD WHEN THE DRILL IS PULLED OUT. IT LOOKS LIKE A SMALL METAL HOLDING PIN IS PERHAPS TOO LOOSELY HELD IN PLACE AND FALL OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRANIAL ACCESS KIT W/TWIST LOCK DRILL GUARD CRANIAL ACCESS HBF INTEGRA LIFESCIENCES CORP. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *