BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TARGET DEVICE 300X160MM

    MDR report key: 2531959 · Received April 9, 2012

    Report

    Report Number
    9610622-2012-00165
    Event Type
    Malfunction
    Date Received
    April 9, 2012
    Date of Event
    March 21, 2012
    Report Date
    March 23, 2012
    Manufacturer
    STRYKER OSTEOSYNTHESIS KIEL
    Product Code
    LXH
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ONCE THE INVESTIGATION HAS BEEN COMPLETED ANY ADDITIONAL INFO WILL BE REPORTED IN A SUPPLEMENTAL REPORT. ASSOCIATED DEVICE: (B)(4) TROCHANTERIC NAIL KIT, TI 11X180MM X 125, LOT K128753; 13200090 NAIL HOLDING SCREW 8X35MM, LOT UNK; 13200065 SCREWDRIVER 8MM, BALL-TIP, T-HANDLE 8X330MM, LOT K448154.

    Description of Event or Problem · 1

    OUR SALE REP REPORTED THAT DURING A SURGERY PROCEDURE IT WAS NOT POSSIBLE TO MAKE THE NAIL OFF OF THE TARGET DEVICE. THEY TRIED TO REMOVE ALL SCREWS FROM THE TARGET DEVICE BUT IT WAS NOT POSSIBLE. THEY NEEDED TO IMPLANT A NEW NAIL WITH THE SAME CERVICAL HOLE AND DISTAL HOLE. THEY USED A NAIL EXTRACTION ADAPTER. AT THE END THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TARGET DEVICE 300X160MM INSTRUMENT LXH STRYKER OSTEOSYNTHESIS KIEL NA KME902914

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other