BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VA LOCKSCR Ø2.4 SELF-TAP L18 TAN

    MDR report key: 2893775 · Received January 2, 2013

    Report

    Report Number
    1719045-2013-00003
    Event Type
    Malfunction
    Date Received
    January 2, 2013
    Date of Event
    November 30, 2012
    Report Date
    December 4, 2012
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HWC
    PMA / PMN Number
    K102694
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT NOT DIAGNOSIS. DHR WAS REVIEWED WITH NO COMPLAINT RELATED ANOMALIES NOTED.

    Additional Manufacturer Narrative · 1

    A MANUFACTURING EVALUATION WAS CONDUCTED AND THE REPORT INDICATES THE SCREW IS WHOLE AND INTACT. ITS DIAMETER, LENGTH, AND GENERAL CONFIGURATION CONFIRM IT WAS A 2.4MM VA LOCKING SCREW STARDRIVE 18MM. THE DRIVE HAS NO APPARENT DAMAGE. THE TOP OF THE HEAD IS IN GOOD CONDITION. TWO HEAD THREADS HAVE SLIGHT COMPRESSION OF THE MAJOR DIAMETER AT APPROX. THE MIDDLE OF THE HEAD AND TOWARDS THE THREAD EXIT. THE SHAFT THREADS ARE IN GOOD CONDITION, AS ARE THE FLUTES AND THE TIP. THE RELEVANT DIMENSIONS THAT COULD BE CHECKED ARE WITHIN SPECIFICATION. DUE TO THE TYPE OF DAMAGE INCURRED, A FINITE EVALUATION COULD NOT BE PERFORMED.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: DURING A DISTAL RADIUS FRACTURE PROCEDURE, THE SCREW WOULD NOT LOCK. THE SURGEON CHOSE VARIABLE ANGLE (VA) MODE. THE SURGEON INSERTED THE VA LOCKING SCREWS IN A POSITIONING HOLE AFTER DRILLING. REPORTEDLY THE SURGEON COULD NOT LOCK THE VA LOCKING SCREW IN THE DISTAL ROW SECOND ULNA HOLE. HE STOPPED INSERTING SCREW CLOSE TO PENETRATION. HE PLANED THIS SCREW RESTED IN PATIENT BODY. IT WAS REPORTED HE HAD A PROBLEM WITH THE SCREW DUE TO LENGTH. THE SURGEON THEN CHANGED AND INSERTED OTHER NEW SCREW. THE NEW SCREW COULD BE LOCKED IN THIS HOLE. HE CHOSE VA MODE, HE USED TORQUE LIMITER, 0.8NM, IN LOCK. THIS IS 1 OF 2 REPOTS FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    734 VA LOCKSCR Ø2.4 SELF-TAP L18 TAN VA LOCKING SCREW HWC SYNTHES MONUMENT 8100694

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR PLATE