BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.0MM DRILL BIT WITH DEPTH MARK/QC/140MM

    MDR report key: 2251153 · Received August 10, 2011

    Report

    Report Number
    1719045-2011-00545
    Event Type
    Malfunction
    Date Received
    August 10, 2011
    Date of Event
    July 15, 2011
    Report Date
    July 15, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    HTW
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MFG DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RETURNED.

    Description of Event or Problem · 1

    DURING A TARSAL-METATARSAL FUSION PROCEDURE, THE DRILL BIT TIP BROKE OFF IN THE BONE. SURGEON ATTEMPTED TO INSERT THE SCREW BEFORE DISCOVERING THAT THE DRILL BIT TIP HAD BROKEN OFF. X-RAYS CONFIRMED BROKEN FRAGMENT WAS LODGED IN BONE. SURGEON WAS UNABLE TO RETRIEVE THE FRAGMENT WITHOUT COMPROMISING THE REST OF THE PROCEDURE. PROCEDURE WAS COMPLETED, SURGEON NOTED WHEN FUSION IS ACHIEVED, HE WILL BE ABLE TO RETRIEVE THE FRAGMENT AT THE TIME OF EXPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 2.0MM DRILL BIT WITH DEPTH MARK/QC/140MM 2.0MM DRILL BIT WITH DEPTH MARK HTW SYNTHES GMBH F-11406

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR