BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERCL-CABLE W/CRIMP Ø1.7

    MDR report key: 2943569 · Received February 5, 2013

    Report

    Report Number
    1719045-2013-00260
    Event Type
    Malfunction
    Date Received
    February 5, 2013
    Date of Event
    December 12, 2012
    Report Date
    January 10, 2013
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    JDQ
    PMA / PMN Number
    K992616
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. THE COCR CERCL-CABLE WITH CRIMP CONFORMED TO ALL REQUIREMENTS ACCORDING TO THE CERTIFICATE OF CONFORMANCE, DATED (B)(4) 2012. THE LOT WAS INSPECTED AND CONFORMED TO THE SYNTHES INCOMING FINAL INSPECTION SHEET. THERE WERE NO MRRS, NCRS, OR COMPLAINT-RELATED ISSUES WITH THIS LOT. THE SUPPLIER REVIEWED THE DHR AND DETERMINED THAT THE DEVICE MET ALL SPECIFICATIONS PRIOR TO SHIPPING. THE CERCLAGE WAS INSPECTED FOR THE TWO BARREL FEATURES AND PASSED INSPECTION. THE WELDED BEAD ON THE CABLE WAS UNABLE TO BE INSPECTED DUE TO POTENTIAL MATERIAL TRANSFER. THE CABLE DIAMETER WAS INSPECTED IN THREE LOCATIONS AND PASSED INSPECTION.

    Additional Manufacturer Narrative · 1

    ADDITIONAL EVALUATION WAS PERFORMED. THE REPORT INDICATES THE SUPPLIER REVIEWED THE DHR AND DETERMINED THAT THE DEVICE MET ALL SPECIFICATIONS PRIOR TO SHIPPING. THE DIMENSIONAL INSPECTION OF THE CABLE WAS UNABLE TO BE PERFORMED ON THE WELDED BEAD FEATURE DUE TO THE LIKE HOOD OF SOME MATERIAL DEFORMATION THAT MAY HAVE OCCURRED AS THE BEAD PASSED THROUGH THE CERLAGE. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    A DEVICE REPORT FROM SYNTHES (B)(4) PROVIDES INFORMATION FROM A FACILITY IN (B)(6) REGARDING A COCR CABLE WITH CRIMP USED DURING A PROCEDURE TO TREAT A STEM DISTAL FEMORAL FRACTURE. IT WAS REPORTED THAT DURING THE OPERATION, THE CRIMP BALL PASSED THROUGH THE CERCLAGE. AFTER THE PHYSICIAN INSERTED THE CABLE USING WITH THE CABLE PASSER, HE ATTEMPTED TO APPLY PRESSURE TO THE CABLE TENSIONER. HOWEVER, THE CRIMP BALL DID NOT HOLD AND PASSED THROUGH THE CERCLAGE. THE PHYSICIAN CHECKED THE CERCLAGE CABLE AND FOUND THAT THE DIAMETER OF THE CERCLAGE BALL APPEARED TO BE SMALLER THAN THE DIAMETER OF THE CERCLAGE HOLE. THE PHYSICIAN USED A NEW CERCLAGE CABLE WITH CRIMP AND COMPLETED THE FIXATION TO THE CABLE TENSIONER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48419 CERCL-CABLE W/CRIMP Ø1.7 COCR CABLE WITH CRIMP JDQ SYNTHES MONUMENT 8006467

    Patients

    Seq Age Sex Outcome Treatment
    1