BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCREWDRIVER

    MDR report key: 3050410 · Received April 10, 2013

    Report

    Report Number
    1030489-2013-00976
    Event Type
    Malfunction
    Date Received
    April 10, 2013
    Date of Event
    March 8, 2013
    Report Date
    May 3, 2013
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    HXX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. VISUAL AND OPTICAL INSPECTION IDENTIFIED WEAR AT THE INITIAL PORTION OF THE FAS HEAD INTERFACE APPEARS WORN; NO MATERIAL OR FUNCTIONAL ISSUE NOTED. FUNCTIONAL EVALUATION WITH SAMPLE SCREW DID NOT IDENTIFY ISSUE WITH FULL ENGAGEMENT OF BOTH DRIVERS. UNABLE TO REPLICATE CUSTOMER CONCERN; AFTER VISUAL, OPTICAL AND FUNCTIONAL EVALUATION, NO EVIDENCE WAS FOUND THAT WOULD SUGGEST A DEFECT IN MANUFACTURING OR PROCESSING OF THE INSTRUMENT OR ASSOCIATED COMPONENTS. THE INSTRUMENT APPEARS TO BE CAPABLE OF PERFORMING ITS INTENDED FUNCTION.

    Additional Manufacturer Narrative · 1

    (B)(4): THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION; THEREFORE, THE CAUSE OF THE EVENT CANNOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN SPINAL PROCEDURE FOR SCOLIOSIS AT T4-L4. IT WAS REPORTED THAT THE TIP OF THE SCREWDRIVER CROSS THREADED AND SHEARED OFF METAL DEBRIS FROM THE SCREWS. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    153155 SCREWDRIVER SCREWDRIVER HXX MEDTRONIC SOFAMOR DANEK USA, INC NA OT12E005

    Patients

    Seq Age Sex Outcome Treatment
    1