BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERILE PELVIS KIT HOFFMANN II 4MM APEX

    MDR report key: 1621168 · Received February 23, 2010

    Report

    Report Number
    8031020-2010-00022
    Event Type
    Malfunction
    Date Received
    February 23, 2010
    Date of Event
    January 29, 2010
    Report Date
    February 1, 2010
    Manufacturer
    STRYKER OSTEOSYNTHESIS SELZACH
    Product Code
    JEC
    PMA / PMN Number
    K952730
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS LOST BY THE HOSPITAL. NO EVALUATION WILL BE PERFORMED. IF THE DEVICE OR ADDITIONAL INFORMATION BECOMES AVAILABLE, IT WILL BE SUBMITTED ON A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    DURING HOFFMANN PELVIS KIT SURGERY, THE SURGEON TRIED TO DRILL USING THE DRILL OF 3.2MM DIAMETER INTO THE WING OF THE ILIUM OF PATIENT. HOWEVER, THE TIP OF DRILL WAS BROKEN WHEN THE TIP OF THE DRILL WAS INSERTED IN WING OF ILIUM OF PATIENT BY ABOUT 3CM. AFTERWARDS, THE SURGEON COULD NOT REMOVE THE BROKEN TIP OF DRILL. THE WOUND WAS CLOSED AS THE TIP OF DRILL WAS LEFT IN THE PATIENT. THE SURGEON IS REQUESTING THE INVESTIGATION OF RISK ANALYSIS ON THE TIP OF DRILL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STERILE PELVIS KIT HOFFMANN II 4MM APEX IMPLANT JEC STRYKER OSTEOSYNTHESIS SELZACH NA U03065

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Other