BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORIGINAL STEINH USER RAMUS CHISEL, SLIGHTLY CURVED

    MDR report key: 1791521 · Received August 9, 2010

    Report

    Report Number
    8010177-2010-00278
    Event Type
    Malfunction
    Date Received
    August 9, 2010
    Date of Event
    July 6, 2010
    Report Date
    July 6, 2010
    Manufacturer
    STRYKER OSTEOSYNTHESIS FREIBURG
    Product Code
    HAO
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION RESULT SHOWS THAT THE DEFORMATIONS AND THE BREAKAGE OF THE OSTEOTOME WAS CAUSED BY VERY HIGH BENDING LOADS DURING SURGERY. THEREFORE, THE INVESTIGATED FAILURE IS ATTRIBUTED TO INAPPROPRIATE USER HANDLING. CONSIDERING THE PREVIOUS INVESTIGATION RESULTS, THERE ARE NO INDICATIONS FOR ANY SYSTEMATIC DESIGN, MATERIAL OR MANUFACTURING RELATED ISSUE. BASED ON THE STATISTICAL EVAL, NO INDICATION WAS FOUND FOR ANY DEVICE RELATED ISSUE.

    Description of Event or Problem · 1

    OSTEOTOME SPLIT DOWN THE SIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ORIGINAL STEINH USER RAMUS CHISEL, SLIGHTLY CURVED INSTRUMENT HAO STRYKER OSTEOSYNTHESIS FREIBURG NA X12

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK