BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CROSSTIE INTRAOSSEOUS FIXATION SYSTEM

    MDR report key: 15501603 · Received September 29, 2022

    Report

    Report Number
    3020584246-2022-00009
    Event Type
    Malfunction
    Date Received
    September 29, 2022
    Date of Event
    December 16, 2016
    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

    BASED ON THE REP'S RECOLLECTION OF THE CASE, THE KIT IN QUESTION COULD HAVE BEEN LOT 101252 OR 101049. DURING THE REVIEW, THE WORK ORDER PICK LISTS WERE EXAMINED FOR EACH LOT AND IT WAS DETERMINED THAT THE RETURNED INSERTER LOT 101148 WAS ONLY USED IN THE PACKAGING OF LOT 101252. UPON FURTHER REVIEW OF LOT 101252, NO EVIDENCE WAS FOUND TO SUGGEST THE DEVICE DID NOT MEET SPECIFICATIONS PRIOR TO DISTRIBUTION. AS WITH OTHER BROKEN CROSSTIE IMPLANTS, THE SURGEON MOST LIKELY APPLIED TOO MUCH SHEAR FORCE ON THE IMPLANT WHILE ATTEMPTING TO IMPLANT. THE REP CONFIRMED THAT THIS IS WHAT HAPPENED DURING THE FIRST INSERTION ATTEMPT. ANOTHER KIT WAS SUCCESSFULLY USED WITHOUT ANY PROBLEMS.

    Description of Event or Problem · 0

    BROKEN CROSSTIE IMPLANT WAS FOUND DURING ECOPAK RECEIVING ON 02/20/2017. REP WAS CALLED FOR QUESTIONS. REP GAVE FACILITY AND DOCTOR NAME AND MENTIONED THAT HE THINKS THE CASE HAPPENED IN (B)(6) OF 2016. THIS INFO WAS USED TO FIND THE INVOICE FOR THE CASE. THIS INVOICE IS THE ONLY CASE WITH THIS DOCTOR IN WHICH MULTIPLE CROSSTIE KITS WERE USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1956578 CROSSTIE INTRAOSSEOUS FIXATION SYSTEM SCREW, FIXATION, BONE HWC CROSSROADS EXTREMITY SYSTEMS 1443-2511 101252 00815432022052

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Female Other