BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAIL HOLDING SCRE WGAMMA3 8X35MM

    MDR report key: 2634056 · Received June 21, 2012

    Report

    Report Number
    9610622-2012-00270
    Event Type
    Malfunction
    Date Received
    June 21, 2012
    Date of Event
    May 18, 2012
    Report Date
    June 8, 2012
    Manufacturer
    STRYKER OSTEOSYNTHESIS KIEL
    Product Code
    LXH
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONCE THE INVESTIGATION HAS BEEN COMPLETED ANY ADDITIONAL INFORMATON WILL BE REPORTED IN A SUPPLEMENTAL REPORT. ASSOCIATED DEVICES: (B)(4), TARGET DEVICE GAMMA3 300X160MM, LOT# KP268546, (B)(4) TROCHANTERIC NAIL KIT, TI GAMMA3 11X180MM X 130 LOT# K240622.

    Description of Event or Problem · 1

    IT WAS REPORTED, THAT WHILE OBSERVING A SURGERY PROCEDURE IT WAS NOT POSSIBLE TO REMOVE THE TARGET DEVICE FROM THE GAMMA NAIL. THEY USED REPLACEMENTS AND THE SURGERY WAS SUCCESSFULLY COMPLETED AT THE END. THERE WAS A DELAY OF 120 MIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NAIL HOLDING SCRE WGAMMA3 8X35MM INSTRUMENT LXH STRYKER OSTEOSYNTHESIS KIEL A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other