BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSITOMIC ACL FLEXIBLE GUIDE PIN

    MDR report key: 1894169 · Received November 5, 2010

    Report

    Report Number
    8043971-2010-00001
    Event Type
    Malfunction
    Date Received
    November 5, 2010
    Date of Event
    October 11, 2010
    Report Date
    November 4, 2010
    Manufacturer
    T.A.G. MEDICAL PRODUCTS, CORP. LTD.
    Product Code
    KCT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION NOT YET COMPLETED SINCE THE INVOLVED DEVICE HAS NOT YET ARRIVED FOR EVALUATION, HOWEVER, THE SURGEON CONFIRMED THAT HE DIDN'T FOLLOW THE SURGICAL TECHNIQUE AS DEFINED IN THE INSTRUCTIONS FOR USE.

    Description of Event or Problem · 1

    ON (B)(6) 2010, IT WAS REPORTED BY THE DISTRIBUTOR THAT A VERSITOMIC ACL FLEXIBLE GUIDE PIN BROKE WHILE BEING DRILLED INTO THE FEMUR OF A PATIENT BY A PHYSICIAN. ACCORDING TO THE DISTRIBUTOR THE FRAGMENT WAS ABLE TO BE REMOVED AND A NEW VERSITOMIC ACL FLEXIBLE GUIDE PIN WAS USED TO FINISH THE PROCEDURE SUCCESSFULLY. IT WAS ALSO REPORTED THAT THERE WAS ONLY A 5 MINUTE DELAY TO THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERSITOMIC ACL FLEXIBLE GUIDE PIN NONE KCT T.A.G. MEDICAL PRODUCTS, CORP. LTD. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Required Intervention