BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CABLE TENSIONER

    MDR report key: 3191566 · Received June 26, 2013

    Report

    Report Number
    1719045-2013-01606
    Event Type
    Malfunction
    Date Received
    June 26, 2013
    Date of Event
    April 22, 2011
    Report Date
    April 27, 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

    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).

    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. SUBJECT DEVICE HAS BEEN RECEIVED AND EVALUATED. A REVIEW OF THE DEVICE HISTORY RECORDS SHOWED NO NONCONFORMANCES. THE DEVICE WAS VISUALLY INSPECTED AND FUNCTIONAL SIMULATIONS WERE PERFORMED WITH TWO DIFFERENT, BUT STANDARD, SIZE WIRES THROUGHOUT THE TENSION RANGE. NO MALFUNCTIONS OCURRED. THE DEVICE WAS CAREFULLY DISASSEMBLED AND NONE OF THE COMPONENTS OF THE ASSEMBLY WERE OUT OF TOLERANCE. NO DEVICE NONCONFORMANCES WERE DETECTED AND IT OPERATED AS INTENDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CABLE TENSIONER, P/N 391.201, WAS USED ALONG WITH DISTRACTION FORCEPS, TO AFFIX A WIRE TO A CONSTRUCT PLATE. THE USER ATTEMPTED TO ADJUST THE TENSION BEYOND THE SETTING OF 20KG BUT THE ADJUSTMENT KNOB ON THE TENSIONER, ALTHOUGH ADJUSTABLE PROVIDED NO INCREASE IN TENSION. THE USER TRIED TO REFIT THE WIRE ON THE TENSIONER BUT WAS UNSUCCESSFUL. THERE WAS NO REPORT OF ANY ILL EFFECT ON THE PATIENT CONDITION AND THERE WAS NO INCREASE IN SURGICAL TIME. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290352 CABLE TENSIONER LXH SYNTHES MONUMENT P049356

    Patients

    Seq Age Sex Outcome Treatment
    1