BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORTSCR Ø1.5 SELF-TAP L12 TAN

    MDR report key: 2932003 · Received January 28, 2013

    Report

    Report Number
    2520274-2013-00674
    Event Type
    Malfunction
    Date Received
    January 28, 2013
    Date of Event
    February 12, 2009
    Report Date
    February 23, 2009
    Manufacturer
    SYNTHES
    Product Code
    DZL
    PMA / PMN Number
    NON-US
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. 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 (B)(4) COMPLAINT HANDLING UNIT REPORTED THAT THE SCREWS WERE BROKEN DURING INSERTION. THE PATIENT HAD A SECOND METACARPAL FRACTURE AND WAS TREATED WITH A 1.5 Y-PLATE. THEN THE SURGEON USED THE CORTICAL SCREWS TO FIX THE PLATE AND THE SCREWS BROKE DURING INSERTION. THE DOCTOR NOTED THAT THE PATIENTS BONE WAS RELATIVELY HARD BECAUSE THE PATIENT IS YOUNG. X-RAYS WERE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    37438 CORTSCR Ø1.5 SELF-TAP L12 TAN CORTICAL SCREW DZL SYNTHES

    Patients

    Seq Age Sex Outcome Treatment
    1