BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CABLE TENSIONER WITH PISTOL GRIP

    MDR report key: 2841366 · Received October 23, 2012

    Report

    Report Number
    1719045-2012-01100
    Event Type
    Malfunction
    Date Received
    October 23, 2012
    Date of Event
    September 25, 2012
    Report Date
    September 25, 2012
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF SYNTHES DEVICE HISTORY RECORDS FOR LOT # P096696 REVEALED THE CABLE TENSIONER W/PISTOL GRIP WAS MANUFACTURED BY PIONEER SURGICAL TECHNOLOGIES. (B)(4). THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS A MANUFACTURING EVALUATION WAS CONDUCTED AND THE REPORT INDICATES: PIONEER SURGICAL TECHNOLOGIES MANUFACTURED THE 1.7MM CABLE W/CRIMP 750MM-STERILE, PART NUMBER (B)(4), LOT NUMBER P116262. THE SUPPLIER REVIEWED THE DHRS AND DETERMINED THAT THE CABLES WERE MADE TO SPECIFICATION AT THE TIME OF MANUFACTURING. THE RETURNED CABLES PASSED THE DIMENSIONAL INSPECTION AS WELL. UNDER MAGNIFICATION, IT WAS NOTICED THAT THERE WERE FRACTURES IN THE CABLE BUT THE CAUSE OF THOSE FRACTURES IS UNKNOWN AS THE CABLE WAS UNIFORM AND FREE OF VOIDS. BASED ON THE SPECIFICATIONS AT THE TIME OF THE ORIGINAL MANUFACTURING, THE UNKNOWN ROOT CAUSE, AND THE INVESTIGATION PERFORMED BY THE SUPPLIER, THIS COMPLAINT IS DEEMED INDETERMINATE FROM A MANUFACTURING POSITION.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS.

    Description of Event or Problem · 1

    DURING A PERI PROSTHETIC FEMUR FRACTURE. SURGEON WAS USING A LOCKING PLATE WITH CABLES ENGAGING A CABLE TENSIONER WITH PISTOL GRIP. WHEN THE TENSIONER HIT 50KG THE STRANDS BEGAN BREAKING, FINAL TIGHTEN MADE THE CABLE BREAK. THE SURGEON REPEATED THE PROCEDURE WITH A NEW CABLE AND AGAIN THE CABLE BROKE. THE THIRD TIME THE SURGEON USED A REGULAR TENSIONER NOT THE TENSIONING GUN, SUCCESSFULLY. THE PROCEDURE WAS DELAYED APPROXIMATELY TEN MINUTES. IT WAS NOTED THERE WAS NO ADVERSE EFFECT TO THE PT NOTED. THE CABLE PIECES WERE RETRIEVED. THIS IS 1 OF 3 REPORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CABLE TENSIONER WITH PISTOL GRIP CABLE TENSIONER LXH SYNTHES MONUMENT P096696

    Patients

    Seq Age Sex Outcome Treatment
    1 CABLE| TENSIONER