BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CABLE TENSIONER

    MDR report key: 3003745 · Received March 14, 2013

    Report

    Report Number
    1719045-2013-10338
    Event Type
    Malfunction
    Date Received
    March 14, 2013
    Date of Event
    November 13, 2011
    Report Date
    November 15, 2011
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    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. INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RECEIVED FOR EVALUATION.

    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. THERE WERE TWO SHIPMENTS OF THIS LOT NUMBER. THE ADDITIONAL PART MANUFACTURE DATE IS 05/31/2006. ORIGINAL AWARENESS DATE IS 11/15/2011. ADDITIONAL INFORMATION WAS AVAILABLE 01/13/2012.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN OPEN REDUCTION INTERNAL FIXATION (ORIF) LEFT PERIPROSTHETIC FEMUR FRACTURE PROCEDURE, THE SURGEON PUT THE CABLE IN THE TENSIONER AND IT WOULD NOT TIGHTEN. THE CABLE BECAME JAMMED INSIDE THE TENSIONER. THE CABLE WAS CUT AND ANY BROKEN PIECES OF THE CABLE WERE REMOVED FROM THE SITE. ANOTHER TENSIONER WAS USED AND THE PROCEDURE WAS COMPLETED. THIS EVENT WAS ORIGINALLY RECEIVED VIA MEDWATCH (B)(4).

    Description of Event or Problem · 1

    THIS IS REPORT 1 OF 1 FOR FILE (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    107381 CABLE TENSIONER LXH SYNTHES MONUMENT P312491

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR