BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.7MM VA LCKNG SCREW

    MDR report key: 2945102 · Received December 28, 2012

    Report

    Report Number
    2520274-2012-04351
    Event Type
    Malfunction
    Date Received
    December 28, 2012
    Date of Event
    November 28, 2012
    Report Date
    November 28, 2012
    Manufacturer
    SYNTHES (USA)
    Product Code
    HRS
    PMA / PMN Number
    K100776
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED. MFG RECORDS COULD NOT BE REVIEWED W/O A LOT NUMBER.

    Description of Event or Problem · 1

    PT SUFFERED LEFT DISTAL TIBIA FRACTURE. THE SURGEON IMPLANTED AN 8-HOLE MEDIAL DISTAL TIBIA PLATE, EIGHT 2.7MM VA LOCKING SCREWS, AND THREE 3.5MM VA LOCKING SCREWS. IT IS REPORTED THAT THE SURGEON HAD DIFFICULTY WITH TWO DISTAL 2.7MM VA LOCKING SCREWS LOCKING TO THE PLATE IN THE ANTERIOR DISTAL MOST 2.7MM VA LOCKING HOLE AND THE CENTER DISTAL MOST 2.7MM VA LOCKING HOLE. WHILE THE SURGEON WAS ATTEMPTING TO INSERT THE 2.7MM SCREWS, THE LOCKING HEAD THREADS WOULD NOT CATCH THE THREADS IN THE PLATE TO LOCK. THE SURGEON REMOVED THE TWO SCREWS AND RE-DRILLED ONE OF THE HOLES THE SCREW WAS IN AND IT WAS ABLE TO LOCK PROPERLY. THE SURGEON LEFT THE OTHER HOLE EMPTY. THIS IS 2 OF 4 REPORTS BEING SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 2.7MM VA LCKNG SCREW 2.7MM VA LCKNG SCREW HRS SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR SCREW