BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VA-LCP DORS-DRP-L2.4 LEFT-ANGL SHAFT 3HO

    MDR report key: 3556397 · Received January 7, 2014

    Report

    Report Number
    2520274-2013-08036
    Event Type
    Malfunction
    Date Received
    January 7, 2014
    Date of Event
    December 12, 2013
    Report Date
    December 12, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HRS
    PMA / PMN Number
    K102694
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED. PLACEHOLDER.

    Description of Event or Problem · 1

    A REPORT FROM (B)(4) FOR AN EVENT IN (B)(6) AS FOLLOWS: RADIAL PLATE 04.115.131 WAS IMPLANTED AND AFTER USING THE DRILL GUIDE (03.110.000) AND 1.8MM DRILL BIT (310.509), 2X 2.4MM LOCKING SCREWS (8MM) WERE INSERTED INTO THE MOST DISTAL PLATE HOLES USING A 0.8NM TORQUE LIMITER AND SCREWDRIVER. BOTH SCREWS WERE ABLE TO BE ADVANCED DOWN THROUGH THE PLATE CAUSING THE LOCKING HOLES TO DEFORM. AT THIS POINT THE SURGEON CEASED ADVANCING THE SCREW, SUCH THAT THE TORQUE LIMITER NEVER RATCHETED. A SUBSEQUENT 2.4MM LOCKING SCREW WAS IMPLANTED IN THE MOST PROXIMAL HOLE OF THE PLATE WHICH PERFORMED AS EXPECTED. THIS IS REPORT 1 OF 5 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    10651 VA-LCP DORS-DRP-L2.4 LEFT-ANGL SHAFT 3HO HRS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR