BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERCL-CABLE W/CRIMP Ø1.7

    MDR report key: 3193344 · Received June 27, 2013

    Report

    Report Number
    2520274-2013-03120
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Report Date
    February 21, 2011
    Manufacturer
    SYNTHES, USA
    Product Code
    LRN
    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. 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. (B)(6). DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. THE DEVICE HISTORY RECORD COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO LOT NUMBER WAS PROVIDED. EACH RAW MATERIAL¿S RECEIVING INSPECTION ENSURES THAT ALL SYNTHES IMPLANTS ARE MADE FROM MATERIALS WHICH CORRESPOND TO THE REQUIREMENTS OF INTERNATIONAL STANDARDS AND SPECIFICATIONS. THE ADDITIONAL INVESTIGATION FOUND THAT THE FRACTURE OF THE CERCLAGE CABLE RUNS FOR SOME 110MM FROM THE FIXATION PORTION. THE PATH OF CRACK OF THE CERCLAGE CABLE IS VERY NON-HOMOGENEOUS, SO THAT IT CAN BE CONJECTURED THAT FIRST SOME OF THE FILAMENTS HAVE FAILED AND FOLLOWING THAT THE UNWINDING PROCESS SET IN SITU. IN TWO ADDITIONAL PLACES ISOLATED FILAMENTS WERE BROKEN AS A BUNDLE. RIGHT NEAR ONE OF THESE INDIVIDUAL FILAMENT CRACKS FOUR DENTINGS OF THE CABLE WERE VISIBLE, WHICH PROBABLY WERE CAUSED BY A CUTTING TOOL. AT THE SECOND PLACE FURTHER UNDERNEATH THE CRACK THE BROKEN FILAMENT ENDS ARE BENT IN THE OPPOSITE DIRECTION. THIS COULD BE EXPLAINED BY THE RETREAT OF THE CLAMP AFTER THE CRACK OF THE INDIVIDUAL FILAMENTS. UPON FRACTOGRAPHIC ANALYSIS WITH THE SCANNING ELECTRON MICROSCOPE (SEM) DUCTILE FRACTURE ALVEOLAE COULD BE IDENTIFIED ALONG THE FRACTURE LINES OF INDIVIDUAL FILAMENTS, A CLEAR SIGN OF A DUCTILE FORCED FRACTURE. ADDITIONALLY, STRONG DEFORMATIONS COULD BE IDENTIFIED IN SOME FILAMENTS. ATYPICALLY SMOOTH SURFACES AND OVALLY DEFORMED FILAMENTS AT THE CRACK END MAKE ONE PRESUME THE DEFORMATION VIA AN INSTRUMENT. UNDER TENSILE LOAD THIS RESULTED IN THE FAILURE OF INDIVIDUAL FILAMENTS SO THAT THE WIRE WAS WEAKENED IN SECTION AND THIS EVENTUALLY RESULTED IN THE FULL FAILURE OF THE CERCLAGE CABLE.

    Description of Event or Problem · 1

    PASSER CABLE WITH CLAMP 0.17 CERCLAGE CABLE SNAPPED DURING SURGERY. THIS IS 1 OF 1 REPORT FOR EVENT # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293723 CERCL-CABLE W/CRIMP Ø1.7 LRN SYNTHES, USA

    Patients

    Seq Age Sex Outcome Treatment
    1