BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BONE SCREWS, CROSS-PIN, SELF-DRILLING, DIAM.1.2X3MM, UPPERFACE, (5/PACKAGE)

    MDR report key: 3183046 · Received June 21, 2013

    Report

    Report Number
    0008010177-2013-00125
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Date of Event
    May 23, 2013
    Report Date
    May 28, 2013
    Manufacturer
    STRYKER OSTEOSYNTHESIS-FREIBURG
    Product Code
    JEY
    PMA / PMN Number
    K022185
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL INVESTIGATION SHOWED THAT THE SCREW HEAD SHOWED DEFORMATIONS IN TURN IN AND TURN OUT DIRECTION WHICH WERE CAUSED BY AXIAL, BENDING AND TORSIONAL OVERLOAD. DUE TO THESE OBSERVATIONS NO PROPER PICKING-UP WAS POSSIBLE. FURTHERMORE, THE STRONG DAMAGES ON THE SCREW HEADS SHOWED THAT THE SCREW HAD BEEN INSERTED INTO THE BONE BEFORE. ALL MEASUREABLE DIMENSIONS WERE WITHIN THE SPECIFIED VALUES. DURING INVESTIGATION, NO INDICATION WERE FOUND FOR ANY SYSTEMATIC, MATERIAL OR MANUFACTURING RELATED ISSUE.

    Additional Manufacturer Narrative · 1

    INVESTIGATION IN PROGRESS BUT NOT YET COMPLETE.

    Description of Event or Problem · 1

    DURING SURGERY THE SCREW HEAD SNAPPED OFF FROM THE SCREWDRIVER. THE SURGEON USED OTHER SCREWS FOR THE PROCEDURE.

    Description of Event or Problem · 1

    DURING SURGERY THE SCREW HEAD SNAPPED OFF FROM THE SCREWDRIVER. THE SURGEON USED OTHER SCREWS FOR THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283687 BONE SCREWS, CROSS-PIN, SELF-DRILLING, DIAM.1.2X3MM, UPPERFACE, (5/PACKAGE) IMPLANT JEY STRYKER OSTEOSYNTHESIS-FREIBURG UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1