BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TARGET DEVICE GAMMA3 300X160MM

    MDR report key: 2882151 · Received November 13, 2012

    Report

    Report Number
    9610622-2012-00526
    Event Type
    Malfunction
    Date Received
    November 13, 2012
    Date of Event
    November 7, 2012
    Report Date
    November 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
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ONCE THE INVESTIGATION HAS BEEN COMPLETED ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT. ADDITIONAL DEVICES: (B)(4) DISTAL TARGETING DEVICE GAMMA3 DISTAL TARGETING R1.5 LOT# KP340967; 1320-5330 FIXATION BOLT GAMMA3 DISTAL TARGETING 9X50MM LOT # K145616; (B)(4) FIXATION BOLT GAMMA3 DISTAL TARGETING 9X50 MM LOT # K174677

    Description of Event or Problem · 1

    DURING GAMMA3 LONG NAIL SURGERY, THE DISTAL TARGET DEVICE AND PROXIMAL TARGET DEVICE COULD NOT BE CONNECTED. THE FIXATION BOLT COULD NOT BE INSERTED. WHEN THE SURGEON USED OTHER PROXIMAL TARGET DEVICE, THE DEVICE AND THE DISTAL TARGET DEVICE COULD BE CONNECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TARGET DEVICE GAMMA3 300X160MM INSTRUMENT LXH STRYKER OSTEOSYNTHESIS KIEL NA KME901886

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other