BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    D/M ONE-SIDED CABLE TENSIONER

    MDR report key: 3022845 · Received March 27, 2013

    Report

    Report Number
    0002249697-2013-01078
    Event Type
    Malfunction
    Date Received
    March 27, 2013
    Date of Event
    March 6, 2013
    Report Date
    March 6, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. DEVICE NOT RETURNED TO THE MANUFACTURER.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING A NON-FUNCTIONAL DALL MILES CABLE TENSIONER WAS REPORTED. THE EVENT WAS NOT CONFIRMED. NO ITEMS ASSOCIATED WITH THE EVENT WERE RETURNED OR MADE AVAILABLE FOR IDENTIFICATION OR EVALUATION. MEDICAL RECORDS RECEIVED AND EVALUATION: NO MEDICAL RECORDS OR X-RAYS WERE MADE AVAILABLE FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORDS COULD NOT BE PERFORMED AS NO LOT INFORMATION WAS PROVIDED. A COMPLAINT HISTORY REVIEW COULD NOT BE PERFORMED AS NO LOT INFORMATION WAS PROVIDED. THE ROOT CAUSE COULD NOT BE DETERMINED .

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SINGLE SIDE TENSIONER COULD NOT TENSIONED CABLE IN THE OP. SO, ANOTHER TENSIONSER AND CABLE (NOT STRYKER PRODUCT) WAS USED INSTEAD OF IT AND THE PROCEDURE WAS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SINGLE SIDE TENSIONER COULD NOT TENSIONED CABLE IN THE OP. SO, ANOTHER TENSIONER AND CABLE (NOT STRYKER PRODUCT) WAS USED INSTEAD OF IT AND THE PROCEDURE WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126725 D/M ONE-SIDED CABLE TENSIONER INSTRUMENT LXH STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other