BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VA-LCP-2-COLUMN DRP2.4 VOLAR NARROW LE S

    MDR report key: 2862259 · Received December 7, 2012

    Report

    Report Number
    8030965-2012-01498
    Event Type
    Malfunction
    Date Received
    December 7, 2012
    Date of Event
    October 30, 2012
    Report Date
    November 8, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    HRS
    PMA / PMN Number
    K092556
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. METHOD: A DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE LOT NUMBER COULD NOT BE FOUND IN SYNTHES RECORDS. IT IS POSSIBLE IT IS A WRONG LOT NUMBER.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: DEVICE WAS USED FOR TREATMENT. 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 (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: DURING A DISTAL RADIUS FRACTURE PROCEDURE THE SURGEON WAS USING A SINGLE PURPOSE DRILL AS WELL AS DRILL SLEEVE, DEPTH GAUGES AND A TORQUE LIMITING DRIVER. ONE OF THE FOUR LOCKING SCREWS WENT THROUGH THE PLATE INTO THE BONE, WHILE THE SURGEON WAS RE-TIGHTENING IT INTO THE MOST DISTAL HOLE AT THE STYLOID PROCESS SIDE WITH THE DRIVER AFTER A GUIDING BLOCK WAS ATTACHED TO THE PLATE. THE OTHER SCREWS WERE SUCCESSFULLY RETIGHTENED BY THE IDENTICAL DRIVER. THIS IS 4 OF 4 REPORTS FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VA-LCP-2-COLUMN DRP2.4 VOLAR NARROW LE S PLATE HRS SYNTHES GMBH 8039892

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR SCREWS