BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    28MM REAMER FOR GLENOID

    MDR report key: 3031431 · Received April 2, 2013

    Report

    Report Number
    1719045-2013-00868
    Event Type
    Malfunction
    Date Received
    April 2, 2013
    Date of Event
    March 6, 2013
    Report Date
    March 6, 2013
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HTO
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Description of Event or Problem · 1

    DURING A TOTAL SHOULDER ARTHROPLASTY, THE THREADS ON A GLENOID REAMER BROKE OFF WHILE ASSEMBLING THE REAMER ON THE BACK TABLE. THE SURGEON SWITCHED TO A LARGER REAMER, THE PROCEDURE WAS THEN COMPLETED WITHOUT FURTHER ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    133894 28MM REAMER FOR GLENOID HTO SYNTHES MONUMENT

    Patients

    Seq Age Sex Outcome Treatment
    1