BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERSAL DRIVER SHAFT

    MDR report key: 1961222 · Received December 21, 2010

    Report

    Report Number
    2249697-2010-01799
    Event Type
    Malfunction
    Date Received
    December 21, 2010
    Date of Event
    November 23, 2010
    Report Date
    November 23, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    LXH
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IF ADDITIONAL INFO BECOMES AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. CATALOG NUMBERS AND LOT CODES OF OTHER DEVICES LISTED IN THIS REPORT: CAT # 2107-1015, LOT # UNK, DESCRIPTION: UNIVERSAL DRIVER SHAFT, MANUFACTURE DATE: UNK.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE TIP OF THE SCREWDRIVER WAS BROKEN DURING THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNIVERSAL DRIVER SHAFT INSTRUMENT LXH STRYKER ORTHOPAEDICS MAHWAH NA F3W7106

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention