BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIO-ANCHOR W DISPOSABLE DRIVER, HI-FI SUTURE

    MDR report key: 2190552 · Received February 27, 2007

    Report

    Report Number
    1017294-2007-00107
    Event Type
    Malfunction
    Date Received
    February 27, 2007
    Report Date
    January 29, 2007
    Manufacturer
    CONMED LINVATEC
    Product Code
    MAI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    NO MEDWATCH FORM REC'D FROM THE USER FACILITY. ALL SECTIONS ON THIS FORM COMPLETED BY THE MFR. INVESTIGATION RESULTS: THE BIO-ANCHOR WAS REC'D FOR INVESTIGATION AND THE REPORTED PROBLEM WAS VERIFIED. A VISUAL EXAMINATION FOUND THE ANCHOR BROKEN OFF ABOVE THE EYELET. PER THE INFO FOR USE (IFU), BREAKAGE CAN OCCUR IF THE PILOT HOLE IS NOT DRILLED TO AN ADEQUATE DEPTH, WITH IMPROPER ALIGNMENT OF THE ANCHOR TO THE PILOT HOLE, IF THE ANCHOR IS LOOSE OR NON-SECURE ON THE DRIVER, IF THE ANCHOR INSERTER IS USED FOR PRYING OR A TWISTING MOTION IS APPLIED DURING USE. IN ADDITION, THE IFU ALSO INFORMS THE USER THAT PROPER ORIENTATION AND ALIGNMENT OF INSTRUMENTS IS IMPORT DURING IMPLANTATION OF THE BIO-ANCHOR TO MINIMIZE POSSIBLE BREAKAGE OF THE ANCHOR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING INSERTION OF THIS BIO-ANCHOR DURING A RIGHT BANKART REPAIR, THE IMPLANT BROKE. THE PROCEDURE WAS COMPLETED WITH INSERTION OF ONE IMPLANT. THERE WERE NO INJURIES REPORTED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIO-ANCHOR W DISPOSABLE DRIVER, HI-FI SUTURE IMPLANT MAI CONMED LINVATEC NA BBC65484

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK SERIAL #: UNK| BIO-ANCHOR DRILL BIT: CATALOG #: C6152,| BIO-ANCHOR DRIVER: CATALOG # C6150, SERIAL #: UNK| SERIAL # UNK| BIO-ANCHOR DRILL GUIDE: CATALOG # C6151,| BIO-ANCHOR LOCATOR: CATALOG # C6153, SERIAL #: UNK