BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI PURPOSE OSTEOTOME, STRAIGHT, 17.5 CM, 6MM WID

    MDR report key: 1661975 · Received April 8, 2010

    Report

    Report Number
    8010177-2010-00181
    Event Type
    Malfunction
    Date Received
    April 8, 2010
    Date of Event
    March 16, 2010
    Report Date
    March 16, 2010
    Manufacturer
    STRYKER OSTEOSYNTHESIS FREIBURG
    Product Code
    HWM
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION SHOWS THAT THE FRACTURE OF THE TIP WAS CAUSED BY TOO HIGH BENDING AND TORSIONAL FORCES - WHEREAS THE BENDING FORCES PREVAILED. INDICATIONS FOR MATERIAL OR MANUFACTURING RELATED PROBLEMS WERE NOT FOUND DURING INVESTIGATION.

    Description of Event or Problem · 1

    DURING A RHINOPLASTY PROCEDURE, THE TIP CAME OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTI PURPOSE OSTEOTOME, STRAIGHT, 17.5 CM, 6MM WID INSTRUMENT HWM STRYKER OSTEOSYNTHESIS FREIBURG NA Y9-9/2008

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK