BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2 HOLE CLAMP, YELLOW MONOTUBE TRIAX 15MM

    MDR report key: 2882157 · Received November 13, 2012

    Report

    Report Number
    8031020-2012-00277
    Event Type
    Malfunction
    Date Received
    November 13, 2012
    Date of Event
    November 1, 2012
    Report Date
    November 5, 2012
    Manufacturer
    STRYKER OSTEOSYNTHESIS SELZACH
    Product Code
    LXH
    PMA / PMN Number
    K803166
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS DISCARDED BY THE HOSPITAL. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    DURING SURGERY, THE SURGEON USED THE MONOTUBE TRIAX. WHEN THE SURGEON WAS TIGHTENING THEM WITH THE WRENCH, ONE OF THE SCREW OF THE CLAMP BROKE. THEREFORE, THE SURGEON CHANGED THE PIN CLAMP TO ANOTHER PIN CLAMP. THE SURGEON MENTIONED THAT HE DID NOT GIVE ANY UNNECESSARY HIGH FORCE TO TIGHTEN THE SCREWS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 2 HOLE CLAMP, YELLOW MONOTUBE TRIAX 15MM IMPLANT LXH STRYKER OSTEOSYNTHESIS SELZACH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR Other