BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HORNET INSERTER, BIOSTINGER IMPLANT 10MM

    MDR report key: 1003240 · Received February 21, 2008

    Report

    Report Number
    1017294-2008-00142
    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. A REVIEW OF PRODUCT HISTORY FOR THE PAST 2 YRS SHOWS NO OTHER REPORTED EVENTS FOR THIS FAILURE MODE. CONMED LINVATEC WILL CONTINUE TO MONITOR THIS PRODUCT FOR FAILURES. THE CUSTOMER ALSO REPORTED THAT FOLLOWING THE ATTEMPTED INSERTION OF THIS 10MM BIOSTINGER IMPLANT, THE SURGEON CHANGED TO A 13MM BIOSTINGER IMPLANT AND WHEN HE TRIED TO INSERT THE 13MM SIZE, THE PRELOADED INSERTER TUBE BENT. THIS EVENT IS REPORTED UNDER MDR 1017294-2008-00143.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING INSERTION OF THIS BIOSTINGER HORNET IMPLANT IN A KNEE ARTHROSCOPY, THE HANDLE DISINTEGRATED WHEN THE GREY CONTROL KNOB WAS PUSHED. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE BIOSTINGER IMPLANT. THERE WAS NO REPORT OF SERIOUS INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HORNET INSERTER, BIOSTINGER IMPLANT 10MM SCREW, FIXATION, BONE HWC CONMED LINVATEC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK