BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TI LOW PROFILE NEURO SCREW SELF-DRILLING 5MM

    MDR report key: 2895117 · Received January 3, 2013

    Report

    Report Number
    1719045-2013-00016
    Event Type
    Malfunction
    Date Received
    January 3, 2013
    Date of Event
    December 5, 2012
    Report Date
    December 5, 2012
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HWC
    PMA / PMN Number
    K022012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SCREW IS BROKEN JUST BELOW THE HEAD. THE CROSS SLOT FEATURE HAS DAMAGE. VISUAL EXAMINATION IS CONSISTENT WITH THE COMPLAINT. SINCE ALL RELEVANT FEATURES COULD NOT BE CHECKED AND THERE WERE NO ISSUES FOUND DURING DIMENSIONAL ANALYSIS ON FEATURES THAT COULD BE INSPECTED AND NO LOT NUMBER WAS PROVIDED.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS THE PRODUCT IS ENTERING THE COMPLAINT SYSTEM. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED.

    Description of Event or Problem · 1

    SYNTHES (B)(6) REPORTED DURING A CRANIOTOMY PROCEDURE, THE SURGEON HAD 3 LOW PROFILE NEURO SELF-DRILLING SCREWS THAT BROKE UPON ATTEMPTED FIXATION. TWO HEADS OF THE SCREWS BROKE OFF AND THE DISTAL TIP FOR THE THIRD SCREW BROKE OFF IN THE BONE. THE TIP OF THE SCREW REMAINS IN THE PATIENTS BONE AS THE SURGEON WAS UNABLE TO RETRIEVE IT. THE OTHER SCREW PIECES WERE RECOVERED AND WILL RETURN ALONG WITH THE SCREWDRIVER BLADE TO SYNTHES USA. TO COMPLETE THE CLOSURE, THE SURGEON SWITCHED TO ANOTHER SCREWDRIVER BLADE IN THE SET AND TO 4MM SELF-DRILLING SCREWS. THE SURGEON DID NOT EXPERIENCE ANY ADDITIONAL PROBLEMS. THIS IS 2 OF 3 REPORTS FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2615 TI LOW PROFILE NEURO SCREW SELF-DRILLING 5MM TI LOW PROFILE NEURO SCREW HWC SYNTHES MONUMENT

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SCREWS