BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CABLE TENSIONER

    MDR report key: 3131869 · Received May 29, 2013

    Report

    Report Number
    1719045-2013-01467
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    October 24, 2010
    Report Date
    January 4, 2011
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    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. (B)(6). THE INVESTIGATION OF THE COMPLAINED DEVICE SHOWS THAT THE HOLDING MECHANISM DOES NOT FUNCTION PROPERLY. VISUAL INSPECTION IDENTIFIED ORGANIC RESIDUES INSIDE THE DEVICE. SEVERAL ANALYSES IDENTIFIED THAT INSUFFICIENT CLEANING PROCEDURE POSSIBLY LED TO SUCH PROBLEMS. DIRTY RESIDUES IN THE CLAMPING MECHANISM AVOID PROPER HOLDING MECHANISMS. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT SHOW CONDITIONS THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT.

    Description of Event or Problem · 1

    DURING A FEMORAL FRACTURE WITH STEM, LCP-DF (DISTAL FEMUR) AND CABLE SYSTEM, WHILE THE SURGEON ATTEMPTED TO TIGHTEN CABLE, THE TENSIONER WENT IDLE AND WOULD NOT TIGHTEN THE CABLE PROPERLY. THIS IS 1 OF 1 REPORT FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237149 CABLE TENSIONER LXH SYNTHES MONUMENT P049356

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR