BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HORNET INSERTER, BIOSTINGER IMPLANT 13MM

    MDR report key: 1003241 · Received February 21, 2008

    Report

    Report Number
    1017294-2008-00143
    Event Type
    Malfunction
    Date Received
    February 21, 2008
    Date of Event
    January 22, 2008
    Report Date
    January 22, 2008
    Manufacturer
    CONMED LINVATEC
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION FINDINGS: THE DEVICE HAS NOT BEEN RETURNED FOR EVAL AT THIS TIME. A FOLLOW-UP REPORT WILL BE FILED ONCE THE DEVICE IS RECEIVED AND EVALUATED. THE CUSTOMER ALSO REPORTED THAT PRIOR TO THIS EVENT WITH A 13MM SIZE BIOSTINGER IMPLANT, THE SURGEON ATTEMPTED TO INSERT A 10MM BIOSTINGER IMPLANT AND THE HANDLE DISINTEGRATED WHEN THE GREY KNOB WAS PUSHED. THIS EVENT IS REPORTED UNDER MDR 1017294-2008-00142.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING INSERTION OF THIS BIOSTINGER HORNET IMPLANT IN A KNEE ARTHROSCOPY, THE PRELOAD INSERTER TUBE BENT. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE BIOSTINGER IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HORNET INSERTER, BIOSTINGER IMPLANT 13MM SCREW, FIXATION, BONE HWC CONMED LINVATEC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NK