BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BONECUTTER

    MDR report key: 2882527 · Received December 20, 2012

    Report

    Report Number
    1219602-2012-00351
    Event Type
    Malfunction
    Date Received
    December 20, 2012
    Date of Event
    November 23, 2012
    Report Date
    November 23, 2012
    Manufacturer
    SMITH & NEPHEW MANSFIELD MANUFACTURING SITE
    Product Code
    HAB
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEFECTIVE BLADE WAS NOT RETURNED FOR EVALUATION; HOWEVER, 10 STERILE BLADES WERE RECEIVED FROM LOT 50684139. A REVIEW OF THE DEVICE HISTORY RECORDS WERE PERFORMED WHICH CONFIRMED NO INCONSISTENCIES. A COMPLAINT HISTORY REVIEW HAS NOT IDENTIFIED ADDITIONAL COMPLAINTS FOR THIS LOT NUMBER ON FILE. THE INVESTIGATION IS ONGOING AT THIS TIME. (B)(4).

    Description of Event or Problem · 1

    SALES REP. REPORTED THAT DURING THE ANKLE ARTHROSCOPY THE BLADE BEGAN SHEDDING IN THE JOINT. DOCTOR TRIED TO REMOVE ALL THE DEBRIS WITH SUCTION, HOWEVER, NOT ALL THE PIECES WERE REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BONECUTTER BLADE,3.5 BONE CUTTER FULL RADIUS HAB SMITH & NEPHEW MANSFIELD MANUFACTURING SITE 7210486 50684139

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening