BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    D/M ONE-SIDED CABLE TENSIONER

    MDR report key: 2685213 · Received July 31, 2012

    Report

    Report Number
    2249697-2012-00973
    Event Type
    Malfunction
    Date Received
    July 31, 2012
    Date of Event
    May 3, 2012
    Report Date
    July 4, 2012
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    LXH
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. THE LOT CODE FOR THE REPORTED DEVICE WAS NOT PROVIDED. SHOULD DEVICE OR ADDITIONAL INFO BECOME AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    (B)(4), LOAN SYSTEM (B)(4), LOT NO. 1003628, WAS SENT TO A CASE AT (B)(6) FOR A CASE ON (B)(6) 2012. NEITHER OF THE SINGLE CABLE TENSIONERS IN THIS KIT WORKED. WHEN THE CABLE WAS THREADED THROUGH THE TENSIONER IT FAILED TO GRIP THE CABLE AND TIGHTEN IT. BOTH TENSIONERS WERE TRIED WITH THE SAME RESULT. NO FURTHER INFO WILL BE AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other