BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CABLE-READY CERCLAGE CABLE WITH CRIMP

    MDR report key: 3038239 · Received April 2, 2013

    Report

    Report Number
    1822565-2013-00578
    Event Type
    Malfunction
    Date Received
    April 2, 2013
    Report Date
    March 6, 2013
    Manufacturer
    ZIMMER, INC.
    Product Code
    HHY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: NO PRODUCT WAS RETURNED FOR INSPECTION, NOR WERE X-RAYS OR OTHER DOCUMENTS PROVIDED. CAUSE CANNOT BE DEFINITIVELY DETERMINED. REVIEW OF THE DEVICE HISTORY RECORDS WAS NOT POSSIBLE AS THE PRODUCT AND/OR LOT NUMBERS REQUIRED FOR RETRIEVAL WERE UNAVAILABLE. IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECIFICATIONS. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT CONTRIBUTION TO THE REPORTED PROBLEM. BASED ON THE AVAILABLE INFO, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADDITIONAL SUBSTANTIVE INFO BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER, INC. CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT A BURROWING EFFECT ON THE LOCKING MECHANISM OCCURRED WHILE TORQUING, RESULTING IN A LOOSE CABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134448 CABLE-READY CERCLAGE CABLE WITH CRIMP TRAUMA PROSTHESIS HHY ZIMMER, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 CABLE-READY CERCLAGE CABLE WITH CRIMP:| CATALOG #00223200418, LOT # UNK