BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    D-M 1.6MM BEADED CABLE SET VIT

    MDR report key: 2971638 · Received February 21, 2013

    Report

    Report Number
    0002249697-2013-00735
    Event Type
    Malfunction
    Date Received
    February 21, 2013
    Date of Event
    January 30, 2013
    Report Date
    January 30, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JDQ
    PMA / PMN Number
    K953818
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS NOTED THAT THE DEVICE WAS DISCARDED BY THE HOSPITAL. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT. (B)(4): DEVICE DISCARDED.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING CRACK/FRACTURE INVOLVING A UD-M 1.6MM BEADED CABLE SET VIT WAS REPORTED. THE EVENT WAS NOT CONFIRMED. DEVICE EVALUATION NOT PERFORMED AS NO ITEMS WERE RETURNED. MEDICAL RECORDS WERE NOT RECEIVED. ALL DEVICES IN THE REPORTED LOT WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. THERE HAVE BEEN NO OTHER EVENTS FOR THE REPORTED LOT. THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE INSUFFICIENT INFORMATION WAS PROVIDED. THE ROOT CAUSE OF THE EVENT IS POTENTIALLY RELATED TO OPERATIVE TECHNIQUE, IT IS OUTLINED IN THE SURGICAL PROTOCOL AND IFU THAT EXCESS TENSION (OVER (B)(6)) CAN LEAD TO CABLE BREAKAGE. FURTHER INFORMATION HOWEVER IS REQUIRED TO COMPLETE A MORE COMPREHENSIVE REVIEW AND TO ESTABLISH A ROOT CAUSE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT CABLE OF DALL MILES WAS BROKEN DURING TIGHTENING IN THA. SO, THE SURGEON USED SPARE PRODUCT AND THE PROCEDURE WAS COMPLETED WITHOUT ANY PROBLEMS AND DELAY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT CABLE OF DALL MILES WAS BROKEN DURING TIGHTENING IN THA. SO, THE SURGEON USED SPARE PRODUCT AND THE PROCEDURE WAS COMPLETED WITHOUT ANY PROBLEMS AND DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76847 D-M 1.6MM BEADED CABLE SET VIT IMPLANT JDQ STRYKER ORTHOPAEDICS-MAHWAH 40219901

    Patients

    Seq Age Sex Outcome Treatment
    1 Other