BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CROSSTIE INTRAOSSEOUS FIXATION SYSTEM

    MDR report key: 15501547 · Received September 29, 2022

    Report

    Report Number
    3020584246-2022-00013
    Event Type
    Malfunction
    Date Received
    September 29, 2022
    Date of Event
    February 24, 2017
    Report Date
    September 26, 2022
    Manufacturer
    CROSSROADS EXTREMITY SYSTEMS
    Product Code
    HWC
    UDI-DI
    00815432022052
    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 1443-2511 LOT 101049) AND THE IMPLANT LOTS (P/N 100060 LOT 100866). WHILE REVIEWING THE LHR FOR THE KIT, IT WAS NOTICED THAT SEVERAL KITS WERE REWORKED BECAUSE THE IMPLANT WAS INCORRECTLY ASSEMBLED ON THE INSERTER. HOWEVER, BECAUSE THE LOT WAS 100 % INSPECTED FOR PART CONFIGURATION, THERE IS NO EVIDENCE TO SUGGEST THAT THE IMPLANTS OR THE PACKAGED KITS DID NOT MEET SPECIFICATIONS PRIOR TO DISTRIBUTION.

    Description of Event or Problem · 0

    BROKEN IMPLANT RECOVERED IN ECOPAK RETURNED BY REP. DETAILS OF CASE WERE OBTAINED DURING A PHONE CALL WITH REP IN WHICH IT WAS STATED THAT THE FAILURE WAS DUE TO THE DOCTOR APPLYING TOO MUCH SHEAR FORCE WHILE ATTEMPTING TO RELEASE THE IMPLANT FROM THE INSERTER. THE PROXIMAL PIECE OF THE BROKEN IMPLANT WAS SUCCESSFULLY REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2942410 CROSSTIE INTRAOSSEOUS FIXATION SYSTEM SCREW, FIXATION, BONE HWC CROSSROADS EXTREMITY SYSTEMS 1443-2511 101049 00815432022052

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Female Other