BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VA LOCKSCR Ø2.4 SELF-TAP L16 TAN

    MDR report key: 3132912 · Received May 29, 2013

    Report

    Report Number
    8030965-2013-02446
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    April 25, 2013
    Report Date
    April 30, 2013
    Manufacturer
    SYNTHES GMBH
    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

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

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: DURING SURGERY FOR A DISTAL RADIUS FRACTURE ON (B)(6) 2013, THE SURGEON INSERTED AND LOCKED 4 VARIABLE ANGLE (VA) LOCKING SCREWS IN THE DISTAL HOLES WITH A GUIDING BLOCK, THEN FIXED WITH A DRIVER AND TORQUE LIMITER. THEN HE INSERTED AND LOCKED TWO 2.7MM CORTICAL SCREWS IN THE PROXIMAL SHAFT HOLES WITH DRIVER AND TORQUE LIMITER. ALL SCREWS COULD BE LOCKED. THE SURGEON TOOK OFF GUIDING BLOCK FIXED VA LOCKING SCREWS WITH DRIVER AND TORQUE LIMITER JUST IN CASE. REPORTEDLY, THE VA LOCKING SCREW IN THE DISTAL ROW MOST STYLOID SIDE WOULD NOT STOP ROTATING. FINALLY THIS SCREW PENETRATED THE PLATE HOLE. THE SURGEON FOUND A METAL, THREAD-LIKE PART WHICH WAS ADHERED IN THE BODY OF THE PATIENT. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236680 VA LOCKSCR Ø2.4 SELF-TAP L16 TAN HWC SYNTHES GMBH 8304911

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR