BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TARGET DEVICE GAMMA3 300 X 160 MM

    MDR report key: 2666680 · Received July 17, 2012

    Report

    Report Number
    9610622-2012-00305
    Event Type
    Malfunction
    Date Received
    July 17, 2012
    Date of Event
    June 17, 2012
    Report Date
    June 27, 2012
    Manufacturer
    STRYKER OSTEOSYNTHESIS ¿ KIEL
    Product Code
    LXH
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ONCE THE INVESTIGATION HAS BEEN COMPLETED, ANY ADD'L INFO WILL BE REPORTED IN A SUPPLEMENTAL REPORT. ASSOCIATED DEVICES: 13250-0065 SCREWDRIVER 8 MM, BALL-TIP, T-HANDLE GAMMA3 8 X 330 MM, (B)(4); 1320-0090 NAIL HOLDING SCREW GAMMA3 8 X 35 MM, LOT UNK; 4130-180 MM X 130, (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED DURING A SURGICAL PROCEDURE OF OSTEOSYNTHESIS WITH A GAMMA NAIL, THE SURGEON WAS NOT ABLE TO DISASSEMBLED THE PRODUCTS. THEY REMAINED (1320-0100, 1320-0090, 4130-1180S) JAMMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TARGET DEVICE GAMMA3 300 X 160 MM INSTRUMENT LXH STRYKER OSTEOSYNTHESIS ¿ KIEL NA KME902963

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other