BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TARGET ADAPTER T2 SCN

    MDR report key: 2634175 · Received June 21, 2012

    Report

    Report Number
    9610622-2012-00274
    Event Type
    Malfunction
    Date Received
    June 21, 2012
    Date of Event
    May 23, 2012
    Report Date
    June 7, 2012
    Manufacturer
    STRYKER OSTEOSYNTHESIS KIEL
    Product Code
    LXH
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONCE THE INVESTIGATION HAS BEEN COMPLETED ANY ADDITIONAL INFO WILL BE REPORTED IN A SUPPLEMENTAL REPORT. ASSOCIATED DEVICES: 1826-1032S SUPRACONDYLAR NAIL T2 SCN 10X320MM, LOT# K912960, 1806-3301 NAIL ADAPTER T2 SCN, LOT# KP329690, (B)(4) NAIL HOLDING SCREW T2 SCN, LOT# K986944.

    Description of Event or Problem · 1

    DURING THE T2 SCN SURGERY, THE SURGEON TRIED TO DRILL THE DISTAL SCREW HOLE (POSITION 1 AND POSITION 4) OF THE NAIL WITH A 5.0MM DRILL BIT. HOWEVER, THE DRILL CAME IN CONTACT WITH THE EDGE OF THE SCREW HOLE OF THE NAIL. THEREFORE, THE SURGEON EXTRACTED THE NAIL FROM THE PT BONE AND CHECKED THE DEVICE. THE DRILL CONTACTED THE EDGE OF SCREW HOLE OF THE NAIL. THEREFORE, THE SURGEON DRILLED THE DISTAL SCREW HOLE USING A 4.2MM DRILL BIT AND USED THE 5MM FULL THREAD SCREW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TARGET ADAPTER T2 SCN INSTRUMENT LXH STRYKER OSTEOSYNTHESIS KIEL NA KP228417

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other