BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1.5MM TI CORTEX SCREW SELF-TAPPING 8MM

    MDR report key: 2940768 · Received February 4, 2013

    Report

    Report Number
    2520274-2013-00750
    Event Type
    Malfunction
    Date Received
    February 4, 2013
    Date of Event
    August 12, 2010
    Report Date
    August 12, 2010
    Manufacturer
    SYNTHES
    Product Code
    HWC
    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. 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

    (B)(4) COMPLAINT HANDLING UNIT REPORTED DURING THE INSERTION OF THE SCREWS, THE SURGEON REPEATEDLY ENCOUNTERED SCREW BREAKAGE. SIZES RANGED FROM 8-13MM / 1.5MM DIAMETER THROUGH 1.5MM PLATE. ALL EIGHT SCREWS IN TOTAL BROKE AND SOME HAD TO BE LEFT IN SITU. THE SURGEON WAS HIGHLY FAMILIAR WITH THE INSTRUMENTS AND IMPLANTS AND HAD NOT ENCOUNTERED THIS NUMBER OF BREAKAGES IN ONE CASE. THE SURGEON MENTIONED THAT COMPRESSION WAS NOT EVEN DONE DURING INSERTION WHEN THE BREAKAGES HAPPENED. ALL THE REMAINING SCREWS FOR L8-13MM WERE REMOVED AND ARE ENCLOSED WITH THIS REPORT FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46893 1.5MM TI CORTEX SCREW SELF-TAPPING 8MM 1.5MM TI CORTEX SCREW HWC SYNTHES

    Patients

    Seq Age Sex Outcome Treatment
    1