BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BONE SCREWS, CROSS-PIN, SELF-DRILLING, DIAM. 1.2X4M

    MDR report key: 1872217 · Received October 15, 2010

    Report

    Report Number
    8010177-2010-00389
    Event Type
    Malfunction
    Date Received
    October 15, 2010
    Date of Event
    September 16, 2010
    Report Date
    September 17, 2010
    Manufacturer
    STRYKER OSTEOSYNTHESIS FREIBURG
    Product Code
    JEY
    PMA / PMN Number
    K022185
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR INVESTIGATION. THEREFORE A METALLURGICAL EXAMINATION, INDISPENSABLE IN SUCH CASES, CANNOT BE PERFORMED AND IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE. POTENTIAL ROOT CAUSES FOR A SCREW FRACTURE ARE: BONE WAS HARD WITH RESULTING HIGH TORQUE. APPLICATION OF UNINTENDED LOADS (E.G. INADEQUATE SENSITIVE TIGHTENING OF THE SCREW DURING INSERTION). INADEQUATE SCREWDRIVER/SCREW HEAD CONNECTION (NOT ALIGNED IN THE VERTICAL DIRECTION, INADEQUATE AXIAL ALIGNMENT AND CONTACT). COLLISION WITH OTHER IMPLANT OR INSTRUMENT. BASED ON STATISTICAL EVAL THERE IS NO INDICATION FOR ANY SYSTEMATIC DESIGN, MATERIAL OR MFG ISSUE. THE COMPLAINT IS ADDED TO THE TREND.

    Description of Event or Problem · 1

    "SURGEON WAS INSERTING SCREW INTO PLATE DURING CASE WHEN THE HEAD OF THE SCREW SHEARED OFF."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BONE SCREWS, CROSS-PIN, SELF-DRILLING, DIAM. 1.2X4M IMPLANT JEY STRYKER OSTEOSYNTHESIS FREIBURG NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK