BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORTSCR Ø1.5 SELF-TAP L16 TAN

    MDR report key: 2931998 · Received January 28, 2013

    Report

    Report Number
    2520274-2013-00676
    Event Type
    Malfunction
    Date Received
    January 28, 2013
    Date of Event
    June 2, 2009
    Report Date
    June 18, 2009
    Manufacturer
    SYNTHES
    Product Code
    DZL
    PMA / PMN Number
    K112583
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT. ADDITIONAL PRODUCT CODES FOR THIS REPORT INCLUDE MQN. THIS INDIVIDUAL ADVERSE EVENT REPORT IS BEING MADE IN ACCORDANCE WITH THE SYNTHES MDR EXEMPTION REQUEST DATED OCTOBER 2011. A REVIEW OF THE EVENTS ASSOCIATED WITH THE REQUEST WAS PERFORMED AND IT WAS DETERMINED THAT NONE OF THE EVENTS CONSTITUTES SYSTEMIC ISSUES RELATED TO PRODUCT QUALITY, CHANGES IN PRODUCT DESIGN, METHOD OF USE, OR CHANGES IN EXPECTED RISK THRESHOLDS. REVIEW OF THE DATA ALSO INDICATED NO SIGNIFICANT CHANGE IN RISK/BENEFIT OF EACH PRODUCT CATEGORY, NO EVIDENCE OF DEFICIENCIES IN THE DESIGN, LABELING, OR MANUFACTURE OF THE DEVICE. AS NO LOT NUMBER WAS PROVIDED, NO DEVICE HISTORY RECORD REVIEW CAN BE PERFORMED. THE DEVICE IS NOT BEING RETURNED FOR EVALUATION, NO FURTHER INFORMATION IS AVAILABLE ON THIS EVENT. NO FURTHER INVESTIGATION CAN BE PERFORMED.

    Description of Event or Problem · 1

    THE EU COMPLAINT HANDLING UNIT REPORTED THAT THE SCREW HEAD BROKE DURING INSERTION. THE PATIENT HAD A FRACTURE AND WAS TREATED WITH A RADIUS PLATE AND SCREW. DURING THE INSERTION OF THE SCREW, WHILE FINAL TIGHTENING, THE SCREW HEAD BROKE IN HALF. THE SURGEON WAS ABLE TO RETRIEVE A QUARTER OF THE BROKEN HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    38175 CORTSCR Ø1.5 SELF-TAP L16 TAN CORTICAL SCREW DZL SYNTHES

    Patients

    Seq Age Sex Outcome Treatment
    1