BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1.25MM PLATE REDUCTION WIRE THRDD TIP W/LRG STOP/150MM

    MDR report key: 2954768 · Received February 11, 2013

    Report

    Report Number
    8030965-2013-00361
    Event Type
    Malfunction
    Date Received
    February 11, 2013
    Date of Event
    January 14, 2013
    Report Date
    January 14, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    HRS
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. AN INVESTIGATION AND DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO LOT NUMBER WAS PROVIDED AND THE DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED REGARDING AN ORIF, DISTAL RADIUS. IT WAS REPORTED THAT ON TWO SEPARATE OCCASIONS DURING THE SAME PROCEDURE THE SURGEON INSERTED THE PLATE REDUCTION WIRE AND IT BROKE SUPERIOR TO THE LARGE STOP. THE SURGEON REMOVED THE BROKEN WIRE USING A NEEDLE DRIVER IN BOTH INSTANCES. THE SURGEON USED K-WIRE WITHOUT A LARGE STOP TO HOLD THE PLATE IN PLACE TO COMPLETE THE PROCEDURE. REPORTEDLY, THERE WAS NO FURTHER PROBLEM, AND NO ADVERSE EFFECT TO THE PATIENT WAS NOTED. THIS IS REPORT NUMBER 1 OF 2 FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    59138 1.25MM PLATE REDUCTION WIRE THRDD TIP W/LRG STOP/150MM PLATE REDUCTION WIRE HRS SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR