BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CROSSTIE INTRAOSSEOUS FIXATION SYSTEM

    MDR report key: 15501487 · Received September 29, 2022

    Report

    Report Number
    3020584246-2022-00016
    Event Type
    Malfunction
    Date Received
    September 29, 2022
    Date of Event
    April 26, 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

    BOTH IMPLANTS WERE REMOVED AND K-WIRES WERE USED. THE KIT AND CORRESPONDING IMPLANT LHR'S (LISTED BELOW) HAVE BEEN REVIEWED AND THERE IS NO EVIDENCE TO SUGGEST THE DEVICE DID NOT MEET SPECIFICATIONS PRIOR TO DISTRIBUTION. KIT 1443-2501 LOT 101251 / IMPLANT 100059 LOT 101209. KIT 1443-2511 LOT 101252 / IMPLANT 100060 LOT 101210. THIS FAILURE STEMS FROM ATTEMPTING TO PRESS FIT THE 2.5MM IMPLANT INTO A 2.2MM DRILLED HOLE INTO AN UNSTABLE PROXIMAL PHALANX.

    Description of Event or Problem · 0

    DURING SURGERY, TWO OF THE CROSSTIE IMPLANTS BROKE. A 2.2 REAMER WAS USED DURING PREP. THIS EVENT OCCURRED PRIOR TO THE FIELD UPDATE REGARDING THE USE OF 2.5 REAMERS. THIS FAILURE OCCURRED DUE TO THE DOCTOR TRYING TO FORCE THE 2.5MM IMPLANT INTO THE HOLE DRILLED BY THE 2.2MM REAMER. DURING THIS THE PROXIMAL PHALANX WAS UNSTABLE AND THE IMPLANT BROKE AS RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2928921 CROSSTIE INTRAOSSEOUS FIXATION SYSTEM SCREW, FIXATION, BONE HWC CROSSROADS EXTREMITY SYSTEMS 1443-2501 101251 00815432022045

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other