BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1.5MM TI CORTEX SCREW SELF-TAPPING 9MM

    MDR report key: 3139287 · Received May 31, 2013

    Report

    Report Number
    2520274-2013-02992
    Event Type
    Injury
    Date Received
    May 31, 2013
    Date of Event
    May 6, 2013
    Report Date
    May 6, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    MQN
    PMA / PMN Number
    K981275
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. ADD'L PRO CODE: DZJ. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Description of Event or Problem · 1

    SALES CONSULTANT REPORTS THAT DURING A METACARPAL SURGERY, WHILE SURGEON WAS IMPLANTING A 1.5MM MODULAR HAND 6 HOLE PLATE WITH SCREWS, THE 4TH HOLE DISTAL SCREW HEAD SNAPPED OFF AT THE SHAFT. SURGEON CHOOSE TO NOT REMOVE THE SHAFT AND TO REVISE THE PATIENT TO A 7 HOLE PLATE. THE 6 HOLE PLATE WAS REMOVED AND WAS DISPOSED; THE SCREWS WERE REUSED ON THE 7 HOLE PLATE. X-RAYS WERE TAKEN TO CONFIRM THE SHAFT REMAINS IN THE PATIENT. DUE TO THIS EVENT AN ADDITIONAL 25 MINUTES WERE ADDED TO THE SURGERY AND NO ADDITIONAL ISSUES WERE FOUND. THIS IS 1 OF 2 REPORTS FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    240964 1.5MM TI CORTEX SCREW SELF-TAPPING 9MM MQN SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Required Intervention