BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VA-LCP-2-COLUMN DRP2.4 VOLAR R SHAFT 2HO

    MDR report key: 3190903 · Received June 26, 2013

    Report

    Report Number
    8030965-2013-03980
    Event Type
    Malfunction
    Date Received
    June 26, 2013
    Date of Event
    February 20, 2012
    Report Date
    March 27, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    HRS
    PMA / PMN Number
    K083694
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. (B)(6). A REVIEW OF DEVICE HISTORY RECORDS FOR MANUFACTURING REVEALED NO COMPLAINT RELATED ISSUES. INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED.

    Description of Event or Problem · 1

    COULD NOT LOCK THE SCREW IN PLATE HOLE. THE PATIENT HAD A DISTAL RADIUS FRACTURE, AND DURING THE SURGERY WITH VA-TCP, THE DOCTOR DRILLED THE RADIUS SIDE UNDER THE FIXATION MODE, BUT HE NOTICED THE NECESSITY OF THE ANGLE FOR THE SCREW, HE DRILLED AGAIN OBLIQUELY. HE MEASURED THE DISTANCE AND INTENDED TO INSERT THE SCREW, BUT HE COULD NOT LOCK THE SCREW INTO THE PLATE HOLE. AFTER TRYING, HE COULD NOT PUT THE SCREW IN THE HOLE OF THE PLATE AND THE OPERATION COMPLETED. THIS IS 1 OF 1 REPORT FOR EVENT # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290070 VA-LCP-2-COLUMN DRP2.4 VOLAR R SHAFT 2HO HRS SYNTHES GMBH 3795204

    Patients

    Seq Age Sex Outcome Treatment
    1