BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VARIAX DR AIMING BLOCK FIXATION PIN

    MDR report key: 2915618 · Received January 10, 2013

    Report

    Report Number
    8010177-2013-90011
    Event Type
    Malfunction
    Date Received
    January 10, 2013
    Date of Event
    December 18, 2012
    Report Date
    December 18, 2012
    Manufacturer
    STRYKER OSTEOSYNTHESIS FREIBURG
    Product Code
    LXH
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE REASON FOR THE SERIALIZATION STARTING WITH 90XXX IS TO PROVIDE CLARIFICATION FOLLOWING A CHANGE IN STRYKER¿S ELECTRONIC COMPLAINT SYSTEMS. THE VISUAL INVESTIGATION REVEALED THAT THE STOP PIN, LASER-WIELDED TO THE EXPANDING SLEEVE BROKE DUE TO TOO HIGH BENDING FORCES. THE FRACTURE SURFACE OF THE WELDING SEAM BETWEEN THE STOP PIN AND EXPANDING SLEEVE SHOWED APPEARANCE OF A FORCED RUPTURE. THE GEOMETRY OF THE WELDING SEAM INDICATED THAT THE LASER-WELDING SEAM WAS CORRECTLY PERFORMED. MOREOVER, THE STOP BAR OF THE SCREW SHOWED HEAVY PLASTIC DEFORMATIONS DUE TO THE COLLISION AND FRICTION WITH THE STOP PIN. BECAUSE OF THE TOO HIGH TORSIONAL FORCES ACTING SEVERAL TIMES DURING APPLICATION, TOO HIGH BENDING FORCES DEVELOPED ON THE STOP PIN FINALLY CAUSING BREAKAGE OF THE LASER-WELDING SEAM BETWEEN THE STOP PIN AND EXPANDING SLEEVE. BASED ON THE INVESTIGATION THE ROOT CAUSE WAS ATTRIBUTED TO A USER RELATED ISSUE. INDICATIONS FOR MATERIAL OR MANUFACTURING RELATED ISSUES WERE NOT FOUND IN THE INVESTIGATION. INDICATIONS FOR MATERIAL OR MANUFACTURING RELATED ISSUES COULD NOT BE FOUND IN THE INVESTIGATION.

    Description of Event or Problem · 1

    UPON INSPECTION OF THE RETURNED LONER KIT FROM THE HOSPITAL IT WAS FOUND THAT THE STOP PIN OF THE FIXATION PIN WAS BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    14522 VARIAX DR AIMING BLOCK FIXATION PIN INSTRUMENT LXH STRYKER OSTEOSYNTHESIS FREIBURG NA AC09-09/2012

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK