BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICK-RELEASE SELF-HOLDING SCREWDRIVER

    MDR report key: 3162769 · Received June 11, 2013

    Report

    Report Number
    1030489-2013-02157
    Event Type
    Malfunction
    Date Received
    June 11, 2013
    Report Date
    June 14, 2013
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). (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

    ADDITIONAL INFORMATION: ANALYSIS OF THE RETURNED DEVICE SHOWS THAT THE BREAKAGE IS CONSISTENT WITH OVER TORQUE APPLIED TO THE SCREWDRIVER. A NON-CONFO RMANCE HAS BEEN RECORDED FOR THE LOT NUMBER NM12E007 RELATED TO THE CORRECT NUMBER OF SCREWDRIVERS DELIVERED BY THE SUPPLIER PER THE PURCHASE ORDER. THIS NON-CONFORMANCE HAS NO IMPACT ON THE MECHANICAL RESISTANCE OF THE SCREWDRIVER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SPINAL PROCEDURE. DURING THE PROCEDURE, IT WAS REPORTED THAT THE TIP OF THE SCREWDRIVER BROKE. THE TIP WAS REMOVED AND A NEW DRIVER WAS USED TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262280 QUICK-RELEASE SELF-HOLDING SCREWDRIVER ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH MEDTRONIC SOFAMOR DANEK USA, INC NM12E007

    Patients

    Seq Age Sex Outcome Treatment
    1