BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROD-INTRODUCTPLIERS LONG F/MATRIX 5.5

    MDR report key: 3171653 · Received June 15, 2013

    Report

    Report Number
    8030965-2013-03199
    Event Type
    Malfunction
    Date Received
    June 15, 2013
    Date of Event
    June 1, 2012
    Report Date
    June 12, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    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. (B)(6). MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THERE IS A STRESS MARK AT THE TOP OF THE INNER SLEEVE THAT IS VISIBLE. AT THE POINT WHERE THE INNER SLEEVE IS GOING INTO THE OUTER SLEEVE, SOME FRICTION IS NOTICEABLE AND THE PLIERS ARE SLIGHTLY ROUGH-RUNNING. THE CAUSE IS UNKNOWN.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: DURING A PROCEDURE ON (B)(6) 2012, THE ROD GOT STUCK. WHEN THE SURGEON REDUCED THE ROD WITH THIS PERSUADER, IT GOT STUCK ON THE SCREW HEAD AND WAS ALMOST IMPOSSIBLE TO REMOVE. AFTER A LOT OF EFFORT, THEY FINALLY MANAGED TO GET IT OFF THE SCREW HEAD. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272476 ROD-INTRODUCTPLIERS LONG F/MATRIX 5.5 LXH SYNTHES GMBH T964473

    Patients

    Seq Age Sex Outcome Treatment
    1