BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TENSIONER/CRIMPER/CUTTER F/STERNAL CABLE

    MDR report key: 3171589 · Received June 15, 2013

    Report

    Report Number
    8030965-2013-02993
    Event Type
    Malfunction
    Date Received
    June 15, 2013
    Report Date
    November 2, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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. THE TENSIONING INSTRUMENT WAS RECEIVED BY (B)(4) ON (B)(4) 2011. THERE WAS NO ISSUE IDENTIFIED WITH THIS INSTRUMENT. THE HANDLING WAS OK. THE INSERTION OF THE CABLE THROUGH THE NOSE AND AROUND THE TENSION WHEEL WAS OK. THE TENSIONING FORCE APPLIED SEEMS TO BE CORRECT, WITHOUT BEING ABLE TO DO A PROPER TENSION TESTING OF THE IMPLANT ON A TEST STAND. BASED ON THE FINDINGS AND REVIEW OF THE TECHNIQUE GUIDE, THERE IS EVIDENCE THAT THE USER MAY HAVE TRIED TO INSERT THE CABLE WITHOUT PUSHING THE GOLD COLLAR SLIGHTLY BACK AS DESCRIBED IN THE TECHNIQUE GUIDE, AND THEREFORE UNABLE TO INSERT THE CABLE.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: DURING A PROCEDURE ON AN UNKNOWN DATE, IT WAS DISCOVERED THAT THE WIRE CANNOT BE CLAMPED IN THE TENSIONING INSTRUMENT. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272589 TENSIONER/CRIMPER/CUTTER F/STERNAL CABLE LXH SYNTHES GMBH 132517

    Patients

    Seq Age Sex Outcome Treatment
    1