BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CROSSTIE INTRAOSSEOUS FIXATION SYSTEM

    MDR report key: 15501619 · Received September 29, 2022

    Report

    Report Number
    3020584246-2022-00011
    Event Type
    Malfunction
    Date Received
    September 29, 2022
    Date of Event
    March 22, 2017
    Report Date
    September 26, 2022
    Manufacturer
    CROSSROADS EXTREMITY SYSTEMS
    Product Code
    HWC
    UDI-DI
    00815432022045
    PMA / PMN Number
    K151270
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    LHRS WERE REVIEWED FOR BOTH THE PACKAGED COMPONENT LOTS (P/N 1443-2501 LOT 101930 AND P/N 1444-2500 LOT 100944) AND THE IMPLANT LOTS (P/N 100059 LOT 101890 AND P/N 100059 LOT 100932). NO EVIDENCE WAS FOUND TO SUGGEST THAT THE IMPLANTS OR THE PACKAGED KITS DID NOT MEET SPECIFICATIONS PRIOR TO DISTRIBUTION.

    Description of Event or Problem · 0

    TWO CROSSTIE IMPLANTS WERE BROKEN DURING INSERTION (P/N 1443-2501 LOT 101930 AND P/N 1444-2500 LOT 100944). A THIRD IMPLANT (P/N 1443-2501 LOT 101930) WAS SUCCESSFULLY IMPLANTED BUT THEN REMOVED AFTER TWO WERE BROKEN. THIS WAS DONE DUE TO DOCTOR PREFERENCE. THE IMPLANTS ARE SUPPOSED TO BE RETURNED THROUGH AN ECOPAK. REP CALLED AND GAVE DETAILS REGARDING THE SURGERY WHERE HE REPORTED THE INCIDENT IS DUE TO USER ERROR CAUSED BY TORQUEING THE INSERTER TOO QUICKLY WHILE TRYING TO GET THE IMPLANT TO RELEASE FROM THE INSERTER. ALL THREE IMPLANTS WERE REMOVED AND K-WIRES WERE USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1910314 CROSSTIE INTRAOSSEOUS FIXATION SYSTEM SCREW, FIXATION, BONE HWC CROSSROADS EXTREMITY SYSTEMS 1443-2501 101930 00815432022045

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Unknown Other