BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8.5MM MEDULLARY REAMER HEAD

    MDR report key: 2883344 · Received December 21, 2012

    Report

    Report Number
    8030965-2012-01645
    Event Type
    Malfunction
    Date Received
    December 21, 2012
    Date of Event
    November 27, 2012
    Report Date
    November 27, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    HTO
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. ADDRESS OF FACILITY WAS NOT REPORTED CORRECTLY ON THE INITIAL FOR THIS COMPLAINT EVENT.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED REGARDING AN IM NAILING OF A MID-SHAFT HUMERUS WHICH INCLUDED CANAL REAMING WITH 6MM, 7MM, 7.5MM AND 8MM REAMERS. WHEN THE SURGEON WENT TO THE 8.5MM REAMER, IT BECAME STUCK. HE RAN THE REAMER FORWARD AND IN REVERSE TO FREE IT. THE SURGEON NOTED THAT THREE PIECES OF METAL CAME OFF OF THE REAMING HEAD, WHICH WERE NOT RETRIEVED. THE SURGEON PROCEEDED WITH THE CASE WHICH WAS REPORTEDLY UNEVENTFUL FOR THE REMAINDER OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 8.5MM MEDULLARY REAMER HEAD MEDULLARY REAMER HEAD HTO SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR