BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TARGET DEVICE 300X160MM

    MDR report key: 2481788 · Received March 2, 2012

    Report

    Report Number
    9610622-2012-00116
    Event Type
    Malfunction
    Date Received
    March 2, 2012
    Date of Event
    February 18, 2012
    Report Date
    February 18, 2012
    Manufacturer
    STRYKER OSTEOSYNTHESIS KIEL
    Product Code
    LXH
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO HAS BEEN REQUESTED. IF ADDITIONAL INFO IS RECEIVED IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT. ASSOCIATED DEVICES: (B)(4) SPEEDLOCK SLEEVE 180 LOT# KP306090, (B)(4) NAIL HOLDING SCREW 8X35MM LOT# K542819, (B)(4) TISSUE PROTECTION SLEEVE, LONG 9 MM LOT# K177462, (B)(4) DRILL SLEEVE, LONG 5 MM LOT# K122836.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "FOLLOWING INSERTION OF SHORT GAMMA NAIL ((B)(4) LOT-K660758), WHEN SURGEON ATTEMPTED TO DRILL FOR STATIC DISTAL SCREW, DRILL BIT MISSED AND SKIVED OFF OF NAIL THUS RESULTING IN DRILL HOLE ANTERIOR TO NAIL. SURGEON THEN RETIGHTENED ENTIRE TARGETING ARM AND REATTACHED SPEEDLOCK SLEEVE AND ATTEMPTED TO DRILL FOR DYNAMIC HOLE. DRILL BIT ONCE AGAIN SKIVED OFF OF NAIL, THUS RESULTING IN SECOND ANTERIOR HOLE. THE SURGEON THEN REMOVED THE ENTIRE TARGETING ARM AND USED A SHORT 4.2X180 DRILL BIT TO DRILL A THIRD HOLE UTILIZING THE C-ARM AND WAS ABLE TO INSERT A SCREW THROUGH THE DISTAL HOLE IN THE STATIC SPOT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TARGET DEVICE 300X160MM INSTRUMENT LXH STRYKER OSTEOSYNTHESIS KIEL NA KME902217

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other