BEUDAMED
    FDA Adverse Event Injury Summary report: N

    14.0MM REAMER HEAD-STERILE FORREAMER/IRRIGATOR/ASPIRATOR

    MDR report key: 2841838 · Received November 21, 2012

    Report

    Report Number
    1719045-2012-01192
    Event Type
    Injury
    Date Received
    November 21, 2012
    Date of Event
    October 25, 2012
    Report Date
    October 25, 2012
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HTO
    PMA / PMN Number
    K111437
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. THE MANUFACTURING RECORDS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Description of Event or Problem · 1

    DURING A PROCEDURE USING THE REAMER/IRRIGATOR/ASPIRATOR SYSTEM FOR BONE GRAFT AND THE DRIVE SHAFT AND REAMER BROKE IN THE FEMORAL CANAL OF THE PATIENT. THE SURGEON REMOVED THE PARTS FROM THE CANAL. THE SURGEON DID NOT HAVE ANOTHER DRIVE SHAFT AND REAMER. THE SURGEON THEN USED ALLOGRAFT INSTEAD OF AUTOGRAFT TO COMPLETE THE PROCEDURE. THE PROCEDURE WAS DELAYED FOR APPROXIMATELY TEN MINUTES TO REMOVE THE REAMER FROM THE PATIENT. THE SURGEON REPORTED THE PATIENT IS DOING ALRIGHT. THIS IS 1 OF 2 REPORTS FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 14.0MM REAMER HEAD-STERILE FORREAMER/IRRIGATOR/ASPIRATOR REAMER HEAD HTO SYNTHES MONUMENT 6815258

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Required Intervention DRIVE SHAFT