BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.7MM/3.5MM VA-LCP LAT DISTAL HUMERUS PL 2H/LT/82MM-MED

    MDR report key: 3192590 · Received June 27, 2013

    Report

    Report Number
    2520274-2013-03831
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Date of Event
    May 30, 2013
    Report Date
    May 30, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HRS
    PMA / PMN Number
    K120070
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, 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 COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Description of Event or Problem · 1

    DURING AN OPEN REDUCTION INTERNAL FIXATION (ORIF) DISTAL HUMERUS WITH OLECRANON OSTEOTOMY, TWO UNKNOWN DISTAL VARIABLE ANGLE (VA) LOCKING SCREWS IN THE VA-LCP LATERAL DISTAL (LOCKING COMPRESSION) PLATE DID NOT FULLY ENGAGE IN THE LOCKING HOLES OF THE PLATE. INSTEAD THE SCREWS JUST CONTINUED TO SPIN. THE SURGEON DECIDED TO LEAVE SCREWS IN PLACE RATHER THAN ATTEMPT TO REMOVE THEM. NO PATIENT HARM. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293955 2.7MM/3.5MM VA-LCP LAT DISTAL HUMERUS PL 2H/LT/82MM-MED HRS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1