BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.5MM REAMING ROD WITH BALL TIP/950MM-STERILE

    MDR report key: 3003036 · Received March 13, 2013

    Report

    Report Number
    1719045-2013-00571
    Event Type
    Injury
    Date Received
    March 13, 2013
    Date of Event
    February 20, 2013
    Report Date
    February 20, 2013
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HTO
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. 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

    IT WAS REPORTED THAT DURING A TI CANNULATED HUMERAL NAIL INSERTION ON (B)(6) 2013, SURGEON WAS UNABLE TO REMOVE THE REAMING ROD THROUGH THE CANNULATION OF THE NAIL AFTER THE NAIL WAS IMPLANTED. SURGEON REMOVED THE WIRE, CUT THE BALL AT THE END OF WIRE, AND REMOVED THE NAIL. SURGEON THEN REINSERTED THE WIRE WITHOUT THE BALL, AND REINSERTED THE NAIL WITH NO ISSUES. AN ADDITIONAL 10 MINUTES WAS ADDED TO THE SURGERY. THIS IS 2 OF 2 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105642 2.5MM REAMING ROD WITH BALL TIP/950MM-STERILE HTO SYNTHES MONUMENT

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Required Intervention