BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOCKING SCREW VARIAX FULL THREAD 2.7MM / L14MM

    MDR report key: 4100455 · Received September 19, 2014

    Report

    Report Number
    0008031020-2014-00433
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Date of Event
    August 27, 2014
    Report Date
    August 27, 2014
    Manufacturer
    STRYKER TRAUMA SELZACH
    Product Code
    HRS
    PMA / PMN Number
    K101056
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ONCE THE INVESTIGATION HAS BEEN COMPLETED ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE REPORTED EVENT OF THE SCREW NOT LOCKING COULD NOT BE CONFIRMED. BASED ON THE INVESTIGATION, THE ROOT CAUSE WRONG HANDLING WAS ATTRIBUTED TO A USER RELATED ISSUE. THE VISUAL INSPECTION OF THE SCREW SHOWED DAMAGES ON THE THREAD AND THE LOCKING THREAD. NEVERTHELESS IT WAS POSSIBLE TO LOCK THE SCREW DURING FUNCTIONAL INSPECTION. THEREFORE IT CAN BE ASSUMED THAT THE SCREW WAS SET IN A WRONG ANGLE (SCREW CAN BE LOCKED IN A 30 DEGREE CONE). A REVIEW OF THE DEVICE HISTORY FOR THE REPORTED LOT DID NOT INDICATE ANY ABNORMALITIES. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. NO INDICATIONS OF MATERIAL, MANUFACTURING OR DESIGN RELATED PROBLEMS WERE FOUND DURING THE INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA THE SALES REPRESENTATIVE THAT THE 14MM VARIAX ELBOW SCREW ALLEGEDLY DID NOT LOCK ONTO THE PLATE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA THE SALES REPRESENTATIVE THAT THE 14MM VARIAX ELBOW SCREW ALLEGEDLY DID NOT LOCK ONTO THE PLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584013 LOCKING SCREW VARIAX FULL THREAD 2.7MM / L14MM PLATE, FIXATION, BONE HRS STRYKER TRAUMA SELZACH X13836

    Patients

    Seq Age Sex Outcome Treatment
    1 Other