BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.5MM DRILL BIT/QC/GOLD/110MM

    MDR report key: 1822037 · Received August 25, 2010

    Report

    Report Number
    1719045-2010-00215
    Event Type
    Malfunction
    Date Received
    August 25, 2010
    Report Date
    July 26, 2010
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HTW
    PMA / PMN Number
    K962913
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PT'S WEIGHT DESCRIBED AS (B)(6). THIS INFO WAS NOT PROVIDED BY THE HOSPITAL. ADDITIONAL INFO HAS BEEN REQUESTED. SUBJECT DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED. (B)(4). REVIEW OF THE DEVICE HISTORY RECORD SHOWED NO ANOMALIES OR NONCONFORMANCES.

    Description of Event or Problem · 1

    PT WAS HAVING MULTIPLE LEFT METATARSAL JOINT FUSION PROCEDURES WHEN THE DRILL BIT BROKE OFF INSIDE OF THE LEFT FIRST METATARSAL BONE. THE SURGEON BELIEVED IT WOULD NOT CAUSE HARM TO THE PT BECAUSE IT DID NOT GO THROUGH THE JOINT. PT IS AWARE METAL FRAGMENT WAS NOT REMOVED.

    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 UR78596

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR