BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNIVERSAL QC HEX DRIVER

    MDR report key: 4914515 · Received July 15, 2015

    Report

    Report Number
    1030489-2015-01471
    Event Type
    Injury
    Date Received
    July 15, 2015
    Date of Event
    June 30, 2015
    Report Date
    August 11, 2015
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    HXX
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS:VISUAL AND OPTICAL INSPECTION CONFIRMS THE TIP IS NOT BROKEN. THE TIP HAS BEEN ROUNDED AT THE HEX CORNERS. MATERIAL HARDNESS CONFIRMED TO BE WITHIN PRINT SPECIFICATION. THE AGE OF THE PRODUCT IN ADDITION TO CONFIRMED PROPER HARDNESS SUGGESTS WEAR OVER TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT INTRA-OP, THE TIP OF SCREWDRIVER WAS VERY WORN. THE SCREWS HAD HOWEVER BEEN IMPLANTED.SUBSEQUENTLY, IN A SECOND SURGICAL INTERVENTION, IT WAS DECIDED TO REMOVE THE SCREW BUT IT WAS NOT POSSIBLE AS THE SCREWDRIVER WAS NOT SUITABLE AND THE SCREW HEAD WAS RUINED WHICH DID NOT ALLOW TO EXTRACT THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    460203 UNIVERSAL QC HEX DRIVER SCREWDRIVER HXX MEDTRONIC SOFAMOR DANEK USA, INC NA 8230918

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention