BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9X30MM BIORCI HA SCREW

    MDR report key: 385316 · Received March 26, 2002

    Report

    Report Number
    1219602-2002-00061
    Event Type
    Malfunction
    Date Received
    March 26, 2002
    Date of Event
    February 26, 2002
    Report Date
    March 25, 2002
    Manufacturer
    SMITH & NEPHEW, INC. ENDOSCOPY DIVIS
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING AN ACL PROCEDURE USING THE B-T-B TECHNIQUE, THE BIORCI HA SCREW TIP BROKE WHILE BEING INSERTED. THE TIP REMAINED IN THE PATIENT AND THE SURGEON FOLLOWED IT WITH ANOTHER SCREW OF THE SAME SIZE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 9X30MM BIORCI HA SCREW BIOABSORBABLE SCREW HWC SMITH & NEPHEW, INC. ENDOSCOPY DIVIS NA 507330

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR