BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VA LOCKSCR Ø2.4 SELF-TAP L18 TAN

    MDR report key: 3226104 · Received July 15, 2013

    Report

    Report Number
    1719045-2013-01778
    Event Type
    Malfunction
    Date Received
    July 15, 2013
    Date of Event
    May 21, 2013
    Report Date
    June 17, 2013
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HRS
    PMA / PMN Number
    K102694
    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. LOT NUMBER 8355131 WAS INITIALLY PROVIDED. UPON DHR COMPLETION LOT NUMBER WAS FOUND TO BE INVALID. NO DHR REVIEW WAS POSSIBLE. THE LOT NUMBER PROVIDED WAS NOT FOUND ON THE SYNTHES, (B)(4), DATABASE. NO DHR REVIEW IS POSSIBLE. 510(K) REPORTED INCORRECTLY. UPDATED TO K102694.

    Additional Manufacturer Narrative · 1

    DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED. REVIEW OF MANUFACTURING RECORDS HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED A PATIENT UNDERWENT A DISTAL TIBIAL OSTEOTOMY. THE SURGEON DRILLED WITH GUIDE BLOCK AND TRIED TO INSERT THE VARIABLE ANGLE LOCKING SCREW INTO THE PROXIMAL ROW MOST RADIAL HOLE. SURGEON INSERTED THE SCREW USING THE TORQUE LIMITING ATTACHMENT AND THE SCREW PENETRATED THE PLATE ABOUT 2MM AS SEEN IN X-RAY IMAGE. THE SURGEON REMOVED THE SCREW AND DID NOT REPLACE IT. THE SURGEON NOTED THE SCREW HOLE IN THE PLATE WAS DEFORMED. THIS REPORT IS 1 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    325407 VA LOCKSCR Ø2.4 SELF-TAP L18 TAN HRS SYNTHES MONUMENT 8355131

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR