BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3.5MM SCREWDRIVER

    MDR report key: 1102045 · Received August 7, 2008

    Report

    Report Number
    1649384-2008-00408
    Event Type
    Malfunction
    Date Received
    August 7, 2008
    Date of Event
    July 7, 2008
    Report Date
    August 7, 2008
    Manufacturer
    ABBOTT SPINE
    Product Code
    HXX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT DID NOT OCCUR IN SURGERY. PRODUCT IS AN INSTRUMENT AND IS NOT IMPLANTABLE. DEVICE MANUFACTURER DATE IS UNK. EVALUATION IS PENDING.

    Description of Event or Problem · 1

    ON 07 JUL 2008, THE DISTRIBUTOR REPORTED THAT DURING A REVIEW OF INVENTORY AT THE HOSPITAL THE SALES REP NOTICED THAT THE HANDLE WOULD TURN ALL THE WAY AROUND THE SHAFT OF THE DRIVER SO THE HANDLE WOULD NOT FUNCTION CORRECTLY. WITH ONLY ONE DRIVER IN THE SURGICAL KIT, THERE IS A POTENTIAL FOR A SURGICAL DELAY IF THIS MALFUNCTION WERE TO OCCUR IN SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3.5MM SCREWDRIVER UNIVERSAL CLAMP HXX ABBOTT SPINE 22971

    Patients

    Seq Age Sex Outcome Treatment
    1