BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CABLE CRIMPER

    MDR report key: 1667808 · Received April 23, 2010

    Report

    Report Number
    1719045-2010-00074
    Event Type
    Malfunction
    Date Received
    April 23, 2010
    Date of Event
    April 7, 2010
    Report Date
    April 7, 2010
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HXS
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO HAS BEEN REQUESTED. SUBJECT DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED. INVESTIGATION COULD NOT BE CONCLUDED, NO CONCLUSION COULD BE DRAWN. NO DEVICE HAS BEEN RETURNED. REVIEW OF THE MFG RECORDS WILL BE REQUESTED.

    Description of Event or Problem · 1

    DURING A HIP REVISION PROCEDURE, THE SURGEON HAD REPLACED THE STEM OF THE TOTAL HIP AND THE PT EXPERIENCED A PROXIMAL FEMUR FRACTURE. SURGEON WAS ATTEMPTING TO USE A 1.0MM TI CABLE WITH CRIMP AND THE CABLE CRIMPER. THE CRIMPER WOULD NOT HOLD AND KEPT SLIDING OFF THE CRIMP. WHEN THE SURGEON COULD NOT CRIMP THE CABLES WITH THE CRIMPER, HE ATTEMPTED TO USE A COMPETITIVE DEVICE WHICH ALSO DID NOT CRIMP THE CABLES. THE PROCEDURE WAS EXTENDED AT LEAST ONE HR. THE SURGEON COMPLETED THE PROCEDURE USING ARTHREX FIBER WIRE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CABLE CRIMPER CABLE CRIMPER HXS SYNTHES MONUMENT NA P508134

    Patients

    Seq Age Sex Outcome Treatment
    1 NI CABLES