BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CHISEL BLADE 5MM

    MDR report key: 2920742 · Received January 17, 2013

    Report

    Report Number
    2520274-2013-00440
    Event Type
    Injury
    Date Received
    January 17, 2013
    Report Date
    December 19, 2012
    Manufacturer
    SYNTHES USA
    Product Code
    HSB
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT NOT DIAGNOSIS. INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED. MANUFACTURING RECORDS COULD NOT BE REVIEWED WITHOUT A LOT NUMBER. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. INFORMATION RECEIVED FROM FACILITY.(B)(4): PLACEHOLDER.

    Description of Event or Problem · 1

    A SURGEON WAS USING A CHISEL DURING A REVISION OF A TOTAL HIP AND THE CHISEL BROKE. IT WAS REPORTED THAT THE SURGEON WAS EITHER TRYING TO TAKE OUT THE CEMENT OR THE PROSTHESIS AND THE CHISEL GOT STUCK IN THE CEMENT AND BROKE. PART OF THE CHISEL IS RETAINED IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    25843 CHISEL BLADE 5MM CHISEL BLADE 5MM HSB SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention