BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VA-LCP-2-COLUMN DRP2.4 VOLAR NARR LE SHA

    MDR report key: 3163628 · Received June 11, 2013

    Report

    Report Number
    8030965-2013-02896
    Event Type
    Malfunction
    Date Received
    June 11, 2013
    Date of Event
    October 14, 2011
    Report Date
    October 18, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    HRS
    PMA / PMN Number
    K092556
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE COMPLAINT ANALYSIS WAS PERFORMED IN FOUR STEPS, VISUAL ANALYSIS OF THE RECEIVED PARTS, COMPARISON WITH PARTS FROM A SIMULATION LAB, EVALUATION OF XRAYS AND INSPECTION TO THE HOLES. THE VISUAL INSPECTION OF THE PLATE SHOWS HEAVY DAMAGE ON THE STYLOID HOLES AND SIGNS OF NORMAL USAGE ON ALL OTHER HOLES. THE MOST DISTAL STYLOID HOLE HAS MASSIVE MATERIAL DAMAGES ON THE TOP PROXIMAL AND LOWER DISTAL END, WHICH MUST HAVE BEEN CREATED BY INTERACTION WITH A DRILL BIT OR SOMETHING SIMILAR. THE ANGLE IS SO STEEP THAT IT COULD NOT HAVE BEEN CREATED WITH A MOUNTED GUIDING BLOCK AND A PROPER USAGE OF THE QUICK DRILL SLEEVE. IN THE PROXIMAL STYLOID HOLE, THE RIGHT AND THE UPPER THREADED COLUMN ARE FULLY DAMAGED. THE OTHER TWO COLUMNS ARE ONLY DAMAGED ON THE LOWER PORTION. THE ANALYSIS OF THE SCREW SHOWED DAMAGE OF THE SCREW HEAD ONLY. NO DAMAGE ON THE SCREW SHAFT IS VISIBLE. FINALLY, ALL PERFORMED INVESTIGATIONS CONFIRM THAT NO SCREW CAN BE INSERTED THROUGH TWO COLUMN PLATE NARROW AS LONG AS THE SURGICAL STEPS, AS THEY ARE DESCRIBED IN THE SURGICAL TECHNIQUE, ARE FOLLOWED CORRECTLY. THE COMPLAINT WAS DETERMINED TO BE INVALID AS SIMULATED TESTING COULD NOT CONFIRM THE EVENT. (B)(4).

    Description of Event or Problem · 1

    SCREW WAS RUN THROUGH RADIAL SIDE HOLE. DURING INSERTION OF SCREWS TO PLATE WITH GUIDING BLOCK, THE SCREWS WERE RUN THROUGH THE SIDE HOLE OF DISTAL LOW. THE DOCTOR USED THE TORQUE DRIVER WITH OTHER SCREWS THAT COULD BE INSERTED IN THE HOLE, SO THE PLATE AND SCREWS WERE NOT REMOVED. THIS OPERATION WAS FINISHED. THIS IS 1 OF 6 REPORTS FOR THIS COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    263548 VA-LCP-2-COLUMN DRP2.4 VOLAR NARR LE SHA HRS SYNTHES GMBH 7557933

    Patients

    Seq Age Sex Outcome Treatment
    1