BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VA LOCKSCR Ø2.7 HEAD 2.4 SELF-TAP L24 SS

    MDR report key: 3222738 · Received July 12, 2013

    Report

    Report Number
    2520274-2013-04343
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Date of Event
    June 25, 2013
    Report Date
    June 25, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HRS
    PMA / PMN Number
    K100776
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    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

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: THE SCREW WOULD NOT ENGAGE TO THE PLATE DURING A PROCEDURE ON (B)(6) 2013. SCREW HEAD DID NOT LOCK INTO THE VARIABLE ANGLE (VA) LOCKING HOLE IN THE THIRD MOST PROXIMAL SCREW HOLE. SURGEON FELT THERE MAY HAVE BEEN PLAY IN THE ENGAGEMENT OF THE VA DRILL GUIDE. THE SCREW HEAD THREAD WAS NOT LINED UP TO THE PLATE. IT THEN BECAME STUCK AND REQUIRED A CONICAL SCREW FROM THE DAMAGED SCREW REMOVAL SET TO REMOVE. SURGICAL TIME WAS EXTENDED 20 MINUTES AND THE SCREW HOLE WAS NOT USED. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323988 VA LOCKSCR Ø2.7 HEAD 2.4 SELF-TAP L24 SS HRS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR