BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCREW

    MDR report key: 2924476 · Received January 22, 2013

    Report

    Report Number
    2520274-2013-00500
    Event Type
    Malfunction
    Date Received
    January 22, 2013
    Date of Event
    December 12, 2012
    Report Date
    December 25, 2012
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    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. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (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. IT WAS REPORTED THE SURGEON INSERTED THE SCREW CAREFULLY AND THE SCREW PENETRATED EASILY IN THE PROXIMAL ROW, MOST STYLOID HOLE. THE SURGEON TRIED TO REMOVE THE SCREW THROUGH THE HOLE, BUT HE WAS NOT ABLE TO REMOVE THE SCREW. THE PLATE AND SCREWS REMAINS IMPLANTED IN THE PATIENT. THE PROCEDURE WAS COMPLETED. THE SURGEON CHOSE FIXED MODE AND USED THE TORQUE LIMITER 0.8NM IN LOCK. HE DID NOT USE POWER TOOL DURING INSERTION. THE TOQUE VALUE WAS CHECKED BEFORE SHIPPING AND CLEARED TESTING. THIS IS 2 OF 2 REPORTS FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30293 SCREW HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR PLATE