BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CABLE TENSIONER

    MDR report key: 3083439 · Received April 29, 2013

    Report

    Report Number
    1719045-2013-10967
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Report Date
    July 12, 2012
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    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 DEVICE WAS RETURNED FOR A MANUFACTURING EVALUATION AND IT APPEARED TO BE IN GOOD CONDITION. THERE WAS NO OBVIOUS DAMAGE. PIONEER SURGICAL TECHNOLOGIES MANUFACTURED THE CABLE TENSIONER WITH PISTOL GRIP. THE LOCKING HOLDING SLEEVE PASSED ALL SYNTHES INCOMING INSPECTION AT THE TIME OF MANUFACTURING. THE SUPPLIER INVESTIGATION REVEALED THAT THE CABLE TENSIONER MET THE FINAL INSPECTION REQUIREMENTS. BASED ON THE SPECIFICATIONS AT THE TIME OF THE ORIGINAL MANUFACTURING, THE UNKNOWN ROOT CAUSE, AND THE EVALUATION CONDUCTED BY THE SUPPLIER, THIS COMPLAINT IS DEEMED INVALID FROM A MANUFACTURING POSITION.

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE OR UNCHANGED. 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

    IT WAS REPORTED THAT THE CABLE TENSIONER COULD NOT TIGHTEN THE CABLE. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184457 CABLE TENSIONER LXH SYNTHES MONUMENT P104956

    Patients

    Seq Age Sex Outcome Treatment
    1