BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VA LOCKSCR Ø2.4 SELF-TAP L20 TAN

    MDR report key: 2924437 · Received January 22, 2013

    Report

    Report Number
    1719045-2013-00159
    Event Type
    Malfunction
    Date Received
    January 22, 2013
    Date of Event
    December 21, 2012
    Report Date
    December 25, 2012
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HRS
    PMA / PMN Number
    K102694
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. THE MANUFACTURING RECORDS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. PLACEHOLDER.

    Description of Event or Problem · 1

    DEVICE REPORT FROM (B)(6) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: DURING A DISTAL RADIUS FRACTURE PROCEDURE, AFTER REPOSITIONING AND IMPLANTING THE VA LCP PLATE, THE SURGEON DRILLED THE BONE THROUGH THE GUIDING BLOCK AND QUICK DRILL SLEEVE. HE SLOWLY INSERTED AND LOCKED THE VA LOCKING SCREW THOUGH THE GUIDING BLOCK IN A POSITIONING HOLE. THE SURGEON LOCKED ALL SCREWS BY THE TORQUE LIMITER HANDLE; HOWEVER, THIS SCREW COULDN'T BE LOCKED IN THE PROXIMAL ROW, MOST STYLOID HOLE. REPORTEDLY THIS SCREW WAS FALLEN IN THE HOLE AND THE SURGEON STOPPED SHORT OF PENETRATION FOR THIS SCREW. HE CONFIRMED THE HOLE AND NOTED THAT THE SCREW WENT THROUGH THE HOLE. THE SURGEON COULD REMOVE THE PENETRATED SCREW BUT HE WAS NOT ABLE TO REMOVE THE IMPLANTS; THEREFORE, THE PLATE AND SCREWS REMAINS IMPLANTED IN THE PATIENT. THE SURGEON CHOSE FIXED MODE AND USED THE TORQUE LIMITER 0.8NM IN LOCK BY HAND. THE TOQUE VALUE WAS CHECKED BEFORE SHIPPING AND CLEARED TESTING. THE SURGEON FOLLOWED THE NEW SURGERY GUIDE. IT WAS REPORTED THE SURGEON USED THE GUIDING BLOCK, QUICK DRILL SLEEVE AND TORQUE LIMITER BY FIXED MODE. THE SURGEON DID NOT USED POWER TOOL IN LOCK. THIS IS 2 OF 2 REPORTS FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30202 VA LOCKSCR Ø2.4 SELF-TAP L20 TAN VA LOCKING SCREW HRS SYNTHES MONUMENT 8044684

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR PLATE