BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.5MM DRILL BIT/QC/GOLD/110MM

    MDR report key: 1921025 · Received December 8, 2010

    Report

    Report Number
    1719045-2010-00358
    Event Type
    Malfunction
    Date Received
    December 8, 2010
    Date of Event
    October 28, 2010
    Report Date
    November 8, 2010
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HTW
    PMA / PMN Number
    K962913
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INFO WAS NOT PROVIDED DURING INITIAL REPORT. ADD'L INFO HAS BEEN REQUESTED. (B)(6). SUBJECT DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED. INVESTIGATION IS ONGOING; NO CONCLUSION CAN BE DRAWN AS NO DEVICE WAS RETURNED. REVIEW OF THE MFG RECORDS HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    DURING AN ORIF OF A TIBIA/ANKLE ON A MATURE MALE, THE DRILL BIT BROKE IN THE BONE AND COULD NOT BE REMOVED. SURGEON HAD PLANNED TO IMPLANT A SYNDESMOTIC SCREW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 2.5MM DRILL BIT/QC/GOLD/110MM QUICK COUPLING DRILL BITS HTW SYNTHES MONUMENT NA U122441

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR