BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VA LOCKSCR Ø2.4 SELF-TAP L20 TAN

    MDR report key: 2934869 · Received January 30, 2013

    Report

    Report Number
    1719045-2013-00211
    Event Type
    Malfunction
    Date Received
    January 30, 2013
    Date of Event
    November 4, 2012
    Report Date
    January 4, 2013
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HWC
    PMA / PMN Number
    K102694
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MANUFACTURERS REPORT IS A DUPLICATE OF REPORT # 1719045-2013-00043.

    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

    DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: DURING A SURGERY FOR A DISTAL RADIUS FRACTURE, THE SURGEON INSERTED THE IMPLANTS BY CONDYLAR STABILIZING TECHNIQUE. AFTER REPOSITIONING AND IMPLANTING THE VA LCP PLATE, THE SURGEON DRILLED THE BONE THROUGH THE GUIDING BLOCK AND QUICK DRILL SLEEVE. THE SURGEON INSERTED THE VA LOCKING SCREW THROUGH THE GUIDING BLOCK IN A POSITIONING HOLE. HE THEN LOCKED THE SCREWS BUT COULD NOT LOCK IN THE DISTAL ROW, SECOND STYLOID HOLE AS IT WAS HOLE WAS PENETRATED. THE SURGEON CONTINUED TO ROTATE THE SCREW BY THE TORQUE LIMITER AND WAS ABLE TO GET THE LOCKING SOUND. THE SURGEON CONFIRMED THE SCREW IN THE PATIENTS BODY AND NOTED THAT THIS SCREW WAS PENETRATED. THE PENETRATION SCREW LENGTH COULD NOT BE CONFIRMED. THE SURGEON COULD NOT REMOVE THE SCREW. REPORTEDLY THE SURGEON COULD NOT FEEL LOCKING WHEN HE INSERTED THE VA SCREW (04.210.116S, LOT 8100676) IN MOST PROXIMAL SHAFT HOLE. THE SURGEON CONTINUED TO INSERT THE SCREW WITH THE TORQUE LIMITER AND PROCEEDED WITH CAUTION. THE PROCEDURE WAS COMPLETED. IT WAS REPORTED THE SURGEON CHOSE FIXED MODE AND USED THE TORQUE LIMITER IN LOCK. THIS IS 4 OF 5 REPORTS FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    41352 VA LOCKSCR Ø2.4 SELF-TAP L20 TAN VA LOCKING SCREW HWC SYNTHES MONUMENT

    Patients

    Seq Age Sex Outcome Treatment
    1 PLATE, SCREWS, TORQUE LIMITER