BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TI MATRIXNEURO SCREW SELF-DRILLING 4MM

    MDR report key: 2981370 · Received February 27, 2013

    Report

    Report Number
    1719045-2013-00415
    Event Type
    Malfunction
    Date Received
    February 27, 2013
    Date of Event
    January 29, 2013
    Report Date
    January 29, 2013
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    JEY
    PMA / PMN Number
    K042365
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. THE TIP END IS BROKEN OFF ON THE RETURNED SCREW. THE REMAINDER OF THE SCREW IS IN FAIR CONDITION. THE OVERALL LENGTH AND TIP PROFILE COULD NOT BE CHECKED BECAUSE THE TIP END OF THE SCREW IS BROKEN OFF AND NOT AVAILABLE FOR REVIEW. ALL OTHER FEATURES THAT COULD BE MEASURED MET SPECIFICATIONS. THE MATERIAL WAS TESTED WITH A NITON GUN AND PASSED SPECIFICATIONS. THE SELF-DRILLING ABILITY OF THE SCREWS WAS LOST BECAUSE THE TIPS OF ALL SCREWS WERE DAMAGED. THERE IS NOT ENOUGH INFORMATION TO DETERMINE THE EXACT CAUSE OF FAILURE FOR THESE SCREWS. THE DESIGN RISK ASSESSMENT IS ADEQUATE FOR THE INTENDED USE.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS.

    Description of Event or Problem · 1

    ON (B)(6) 2013, DURING SURGERY FOR A CRANIOTOMY, 3 SCREWS WOULD NOT GO INTO THE BONE. THE SURGEON HAD PRIOR ISSUES WITH THE SAME TYPE OF SCREWS PREVIOUSLY; AS A RESULT HE STOPPED BEFORE THEY BROKE. 12 SCREWS IN TOTAL WERE INSERTED. THE SURGERY WAS DELAYED SLIGHTLY WHILE THE SURGEON TRIED DIFFERENT SCREWS. NO KNOWN ISSUES WITH THE PATIENT. THIS IS 2 OF 3 REPORTS FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    83955 TI MATRIXNEURO SCREW SELF-DRILLING 4MM JEY SYNTHES MONUMENT

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR