BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULL REDUCTION DEVICE FOR 4.3MM PERCUTANEOUS DRILL GUIDE

    MDR report key: 2832274 · Received November 14, 2012

    Report

    Report Number
    8030965-2012-01265
    Event Type
    Malfunction
    Date Received
    November 14, 2012
    Date of Event
    October 19, 2012
    Report Date
    October 19, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, AF
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED REGARDING AN ORIF, DISTAL FEMUR PROCEDURE. A PULL REDUCTION DEVICE WAS USED IN CONJUNCTION WITH A VARIABLE ANGLE DISTAL CONDYLAR PLATE. DURING THE PROCEDURE, THERE WAS A ROTATION CHANGE (UNKNOWN WHICH DIRECTION; INTERNAL TO EXTERNAL OR EXTERNAL TO INTERNAL) THAT CAUSED THE DEVICE TO TORQUE. WHEN THE DEVICE WAS REMOVED, THE TIP OF THE DEVICE WAS BROKEN OFF. THE BROKEN PIECE OF THE DEVICE WAS NOT RETRIEVED FROM THE PATIENT. THERE WAS NO DELAY TO THE PROCEDURE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULL REDUCTION DEVICE FOR 4.3MM PERCUTANEOUS DRILL GUIDE PULL REDUCTION DEVICE LXH SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR