BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VA LOCKSCR Ø2.4 SELF-TAP L16 TAN

    MDR report key: 3132057 · Received May 29, 2013

    Report

    Report Number
    2520274-2013-02921
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    April 25, 2013
    Report Date
    April 30, 2013
    Manufacturer
    SYNTHES USA
    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 MANUFACTURE DATE - 2/1/2013. EXPIRE DATE: 1-FEB-2033. A REVIEW OF THE DEVICE HISTORY RECORDS FOR LOT 7240966 REVEALED THE VARIABLE ANGLE LOCKING SCREW WAS INSPECTED AND THE PART CONFORMED TO ALL REQUIREMENTS. THE MANUFACTURING DOCUMENTS SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    THIS DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A DEVICE HISTORY RECORDS REVIEW HAS BEEN REQUESTED. PLACEHOLDER.

    Description of Event or Problem · 1

    A DEVICE REPORT FROM SYNTHES (B)(4) INDICATED A SURGEON IN (B)(4) REPORTED: DURING SURGERY FOR A DISTAL RADIUS FRACTURE, THE SURGEON INSERTED AND LOCKED 4 VA LOCKING SCREWS IN DISTAL HOLES BY GUIDING BLOCK, AND FIXED BY DRIVER WITH TORQUE LIMITER. SECOND, HE INSERTED AND LOCKED 2.7MM 2 CORT-SCREWS IN PROXIMAL SHAFT HOLES BY DRIVER WITH TORQUE LIMITER. THIRD, HE INSERTED AND LOCKED 2.7MM 2 VA LOCKING SCREWS IN PROXIMAL VA HOLES BY TORQUE LIMITER, BY THIS TIME, ALL SCREWS COULD BE LOCKED. AND THEN HE TOOK OFF GUIDING BLOCK FIXED VA LOCKING SCREWS BY DRIVE WITH TORQUE LIMITER JUST IN CASE. HOWEVER, VA LOCKING SCREW IN DISTAL ROW MOST STYLOID SIDE HAD NOT STOPPED ROTATION. FINALLY THIS SCREW WAS PENETRATED IN HOLE. HE FOUND A METAL PART LIKE THREAD WHICH WAS ADHERED IN THE PATIENT BODY. SURGERY WAS PERFORMED BY GLOBAL TECHNICAL METHOD. HE CHOSE FIXED MODE, AND USED TORQUE LIMITER 0.8NM IN LOCK. THE METAL CHIP IS BEING RETURNED. THIS IS 2 OF 3 REPORTS FOR COMPLAINT (B)(4).

    Description of Event or Problem · 1

    THIS IS 1 OF 3 REPORTS FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236351 VA LOCKSCR Ø2.4 SELF-TAP L16 TAN HWC SYNTHES USA 8304911

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR