BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VA-LCP-2-COLUMN DRP2.4 VOLAR LE SHAFT 2H

    MDR report key: 3101719 · Received May 9, 2013

    Report

    Report Number
    2520274-2013-02465
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Date of Event
    May 15, 2012
    Report Date
    April 15, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HRS
    PMA / PMN Number
    K083694
    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. THE MANUFACTURING RECORDS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN.

    Additional Manufacturer Narrative · 1

    THIS DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. THE INVESTIGATION OF THE COMPLAINED ARTICLES SHOWS THAT THE LOCKING THREAD AT THE SCREW HEADS IS PARTIALLY BADLY DEFORMED. THIS INDICATES CLEARLY MECHANICAL MISHANDLING DURING USE. IT IS POSSIBLE THAT TOO MUCH APPLIED MECHANICAL FORCE WHILE INSERTION MAY HAVE CAUSED THE DEFORMATIONS. THE PLATE THREADS ARE USED BUT OTHERWISE IN GOOD CONDITION. REVIEWING THE MANUFACTURING- AND MATERIAL DOCUMENTATION OF THE PLATE SHOWS CONFORMITY AS WELL. NO PRODUCT FAULT COULD BE DETECTED.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: DURING AN INSERTION OF VARIABLE ANGLE LOCKING SCREWS TO A PLATE, THE TIP OF A SCREW TWISTED. THE SCREWS WERE INSERTED BY HAND. THE PLATE WAS FIXED WITH AN AIMING BLOCK. SIX SCREWS WERE TO BE INSERTED TO THE PLATE, BUT THE SURGEON WAS UNABLE TO FINISH LOCKING IN THE PROXIMAL ROW STYLOID HOLE. AN ADDITIONAL SCREW WAS INSERTED IN THE HOLE AND WAS RUN THROUGH. THE SURGEON REMOVED THE SCREW FROM THE FRACTURE PART OF THE PLATE. THE OPERATION WAS COMPLETED. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202745 VA-LCP-2-COLUMN DRP2.4 VOLAR LE SHAFT 2H HRS SYNTHES USA 7792429

    Patients

    Seq Age Sex Outcome Treatment
    1