BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VA LOCKSCR Ø2.4 SELF-TAP L18 TAN

    MDR report key: 3222705 · Received July 12, 2013

    Report

    Report Number
    8030965-2013-04288
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Date of Event
    May 21, 2013
    Report Date
    June 17, 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 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: THE PATIENT WAS TREATED FOR A DISTAL RADIUS FRACTURE ON (B)(6) 2013. THE SURGEON INSERTED THE SCREW INTO THE PROXIMAL ROW MOST RADIAL HOLE IN THE FIXED MODE BY USING THE GUIDING BLOCK. DURING TIGHTENING OF THE SCREW, IT DIDN'T LOCK INTO THE PLATE AND WENT THROUGH THE BONE UNDER DIRECT VISION. DOCTOR OBSERVED THE SCREW LENGTH WITH DEPTH GAUGE. HE INSERTED SCREW TO USE WITH DRIVER BY HAND. TORQUE LIMITATION ATTACHMENT WAS USED IN THE FINAL LOCKING. THE SURGEON FIXED THE SCREW IN THE APPROPRIATE POSITION. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323338 VA LOCKSCR Ø2.4 SELF-TAP L18 TAN HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1