BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CROSSTIE INTRAOSSEOUS FIXATION SYSTEM

    MDR report key: 15501556 · Received September 29, 2022

    Report

    Report Number
    3020584246-2022-00021
    Event Type
    Malfunction
    Date Received
    September 29, 2022
    Date of Event
    August 24, 2017
    Report Date
    September 26, 2022
    Manufacturer
    CROSSROADS EXTREMITY SYSTEMS
    Product Code
    HWC
    UDI-DI
    00850310006540
    PMA / PMN Number
    K151270
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER CONVERSATION WITH REP, IN THIS CASE A 2.5 MM CROSSTIE IMPLANT WAS INSERTED INTO THE PROXIMAL PHALANX. WHILE ATTEMPTING TO FLIP THE MIDDLE PHALANX ONTO THE IMPLANT, THE IMPLANT BROKE. THE IMPLANT WAS SUCCESSFULLY REMOVED AND CAUSED A MINIMAL DELAY IN SURGERY. ALSO IN THIS CASE, TWO ADDITIONAL IMPLANTS WERE OPENED BUT NOT USED BECAUSE THE DOCTOR DECIDED HE WANTED TO USE A 0 DEGREE IMPLANT RATHER THAN A 10 DEGREE. THERE WAS NO COMPLAINT OR MALFUNCTION INVOLVING THE TWO UNUSED 10 DEGREE IMPLANTS. THE FOLLOWING LHR'S WERE REVIEWED AND NO EVIDENCE WAS FOUND TO SUGGEST THAT THE IMPLANT DID NOT MEET SPECIFICATIONS PRIOR TO DISTRIBUTION. LOT 101051 (REF 1444-2500) PACKAGED PART NUMBER. LOT 100932 (REF 100059) IMPLANT PART NUMBER.

    Description of Event or Problem · 0

    IN THIS CASE A 2.5 MM CROSSTIE IMPLANT WAS INSERTED INTO THE PROXIMAL PHALANX. WHILE ATTEMPTING TO FLIP THE MIDDLE PHALANX ONTO THE IMPLANT, THE IMPLANT BROKE. THE IMPLANT WAS SUCCESSFULLY REMOVED AND CAUSED A MINIMAL DELAY IN SURGERY. ALSO IN THIS CASE, TWO ADDITIONAL IMPLANTS WERE OPENED BUT NOT USED BECAUSE THE DOCTOR DECIDED HE WANTED TO USE A 0 DEGREE IMPLANT RATHER THAN A 10 DEGREE. THERE WAS NO COMPLAINT OR MALFUNCTION INVOLVING THE TWO UNUSED 10 DEGREE IMPLANTS. BROKEN IMPLANT WAS REMOVED AND ANOTHER 0 DEGREE IMPLANT WAS SUCCESSFULLY USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1588767 CROSSTIE INTRAOSSEOUS FIXATION SYSTEM SCREW, FIXATION, BONE HWC CROSSROADS EXTREMITY SYSTEMS 1444-2500 101051 00850310006540

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other