BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CABLE TENSIONER

    MDR report key: 3142494 · Received June 3, 2013

    Report

    Report Number
    1719045-2013-01506
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Date of Event
    April 8, 2011
    Report Date
    April 12, 2011
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BLANK FIELDS ON THIS FORM INDICATE INFORMATION THAT IS UNKNOWN, UNAVAILABLE OR UNCHANGED.

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. THE DEVICE LISTED IN THIS REPORT IS USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. THE DEVICE WAS RETURNED FOR INSPECTION AND THE EVENT WAS CONFIRMED. THE INVESTIGATION HAS SHOWN THAT THE HOLDING MECHANISM DOES NOT FUNCTION AS FORESEEN. DUE TO PREVIOUSLY RECEIVED MARKET FEEDBACK, THE FAILURE OF THIS PHENOMENON HAS ALREADY BEEN IDENTIFIED AND IT CAN HAPPEN THAT DIRT RESIDUES INSIDE THE CLAMPING MECHANISM MAY IMPEDE THE CORRECT CLAMPING. A REVIEW OF SYNTHES DEVICE HISTORY RECORDS FOR THIS LOT REVEALED THAT THIS CABLE TENSIONER WAS MANUFACTURED BY PIONEER SURGICAL TECHNOLOGIES. SYNTHES RECEIVED THREE SHIPMENTS OF THIS LOT AND NO NON CONFORMANCES WERE GENERATED DURING PRODUCTION. THE MANUFACTURING RECORDS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. ALL RECORDS INDICATE THAT THE PRODUCT WAS MANUFACTURED TO SPECIFICATIONS. CONCLUSION ¿ THE COMPLAINT IS CONSIDERED INDETERMINATE FROM A MANUFACTURING PERSPECTIVE AND THE COMPLAINT CONDITION IS DUE TO A DESIGN DEFICIENCY WHEREBY DIRT RESIDUES MAY ENTER THE CLAMPING MECHANISM AND MAY IMPEDE THE CORRECT CLAMPING. THE DEVICE INVOLVED IN THIS EVENT WAS MANUFACTURED BEFORE IMPROVEMENT MEASURES WERE IMPLEMENTED AND A NEW DESIGN IS ALREADY AVAILABLE WHICH HAS ADDITIONAL SLOTS IN THE TENSIONER BODY AND ALLOWS FOR A BETTER CLEANING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS INSUFFICIENT TENSION ON THE CABLES DURING SURGERY. NO TENSION COULD BE GIVEN ON THE CABLES AND NO GRIP WAS POSSIBLE WITH THE CABLE TENSIONER. WE TURNED THE FLUTED KNOB AFTER PASSING THE CABLE, BUT THE KNOB DID NOT REACH THE TENSION WHICH IS MARKED ON THE DEVICE. SOMETIMES WE COULD TURN IT UP TO 20KG AND THEN THE TENSION WAS GONE. NO FURTHER INFORMATION WAS PROVIDED. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244196 CABLE TENSIONER LXH SYNTHES MONUMENT P045897

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR