BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOINTRAFIX SCREW

    MDR report key: 1800123 · Received August 10, 2010

    Report

    Report Number
    1221934-2010-00278
    Event Type
    Malfunction
    Date Received
    August 10, 2010
    Date of Event
    June 1, 2010
    Report Date
    August 2, 2010
    Manufacturer
    DEPUY MITEK
    Product Code
    MBI
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NOTHING IS BEING RETURNED AND NO LOT NUMBER HAS BEEN SUPPLIED, WHICH PRECLUDES CONDUCTING ANY ROOT CAUSE ANALYSIS. THE PROCEDURE WAS EXTENDED BY 1 HOUR, AND IT IS BECAUSE OF THIS THAT THIS REPORT IS ESTABLISHED TO DOCUMENT THE EVENT. AT THIS POINT IN TIME, NO FURTHER ACTION IS WARRANTED. HOWEVER, MITEK WILL CONTINUE TO TRACK ANY RELATED COMPLAINTS WITHIN THIS DEVICE FAMILY AS A MEANS OF MONITORING THE EXTENT WITH WHICH THIS COMPLAINT IS OBSERVED IN THE FIELD.

    Description of Event or Problem · 1

    THE FACILITY IS REPORTING THAT DURING AN ARTHROSCOPIC ACL REPAIR, THE FIXATION SCREW BROKE APART WHILE THE SURGEON WAS INSERTING IT INTO THE BONE TUNNEL, ANOTHER SAME TYPE OF DEVICE WAS PRESSED INTO SERVICE, AND THIS ALSO BROKE APART. ALL OF THE FRAGMENTS FOR BOTH SCREWS WERE REMOVED AND A 3RD SAME TYPE DEVICE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY WITHOUT FURTHER ISSUE OR HARM TO THE PT. THIS ADDED ONE HOUR TO THE PROCEDURE. ALSO SEE ASSOCIATED MDR 1221934-2010-00277.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOINTRAFIX SCREW SOFT TISSUE FIXATION DEVICE MBI DEPUY MITEK 254624 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK