BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CANNULATED DRILL CS 6.5, D4, 4, L220, HUDSON

    MDR report key: 2962074 · Received January 21, 2013

    Report

    Report Number
    8043862-2013-00002
    Event Type
    Malfunction
    Date Received
    January 21, 2013
    Report Date
    January 18, 2013
    Manufacturer
    AAP IMPLANTATE AG
    Product Code
    HTW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED TODAY FOR EVALUATION. INTEGRA LIFE SCIENCE HAS REPORTED AN MDR FORM 3500A (3004608878-2012-00233) AS MANUFACTURER ALTHOUGH AAP IMPLANTATE (B)(4) IS THE LEGAL MANUFACTURER.

    Description of Event or Problem · 1

    GUIDE WIRES WERE PLACED FOR THE 6.5 STAINLESS SCREWS FOR THE SUBTALAR JOINT. SURGEON HAD PLACED TWO GUIDE WIRES THAT CROSSED EACH OTHER THRU THE JOINT. SURGEON WENT TO DRILL OVER THE K-WIRES AND AS HE STARTED TO ADVANCE THE DRILL BIT IT IMPLODED WHILE INSIDE THE BONE. SURGEON HAD ONLY DRILLED FOR ABOUT 2-3 SECONDS WHEN THIS HAPPENED. HE WAS NOT ABLE TO ADVANCE THE DRILL BIT VERY FAR BEFORE IT FELL APART. HE THINKS IT MAY HAVE HIT THE OTHER GUIDE WIRE. HE THEN PULLED THE DRILL BIT OUT AND BEGAN TO RECOVER THE DRILL BIT FRAGMENTS. HE WAS UNABLE TO GET ALL OF IT AND SOME OF THE DRILL BIT WAS LEFT INSIDE THE PATIENT. HE PROCEEDED TO IMPLANT THE SCREW AND HE DID HAVE A CHALLENGE GETTING THE SCREW TO ADVANCE BUT DID GET THE SCREW IMPLANTED. PLEASE ISSUE RMA AND I CAN SEND THE BROKEN DRILL BIT AND FRAGMENTS IN TO BE LOOKED AT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28821 CANNULATED DRILL CS 6.5, D4, 4, L220, HUDSON DRILL HTW AAP IMPLANTATE AG QR0002

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention