BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CABLE TENSIONER

    MDR report key: 3193317 · Received June 27, 2013

    Report

    Report Number
    1719045-2013-01552
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Date of Event
    April 5, 2012
    Report Date
    May 10, 2012
    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). A REVIEW OF DEVICE HISTORY RECORDS FOR MANUFACTURING REVEALED NO COMPLAINT RELATED ISSUES. DURING THE ADDITIONAL EVALUATION WE TRIED TO REMOVE THE JAMMED CABLE FROM THE TENSIONER, BUT IT WAS NOT POSSIBLE. THE CABLE IS STRONGLY JAMMED. WE HAVE TO ASSUME THE EXCEEDING APPLIED FORCE LEAD TO THIS PROBLEM. THEREFORE, WE ARE NOT ABLE TO TEST THE DEVICE IN QUESTION AND ALSO NOT TO FIND OUT THE ROOT CAUSE FOR THE REPORTED PROBLEM.

    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)(4)

    Description of Event or Problem · 1

    DIAL ON THE TENSIONER DIDN''T WORK. THIS IS 1 OF 1 REPORT FOR EVENT (B)(4).

    Description of Event or Problem · 1

    THE PATIENT WAS BEING TREATED FOR SECONDARY FRACTURE AT DIAPHYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292686 CABLE TENSIONER LXH SYNTHES MONUMENT P087813

    Patients

    Seq Age Sex Outcome Treatment
    1