BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.5MM DRILL BIT/QC/GOLD/110MM

    MDR report key: 3183050 · Received June 21, 2013

    Report

    Report Number
    2520274-2013-03663
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Date of Event
    May 24, 2013
    Report Date
    May 24, 2013
    Manufacturer
    SYNTHES (USA)
    Product Code
    HTW
    PMA / PMN Number
    K962913
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND A LOT NUMBER WAS NOT PROVIDED.

    Description of Event or Problem · 1

    DURING A SURGERY ON A FEMALE PATIENT FOR A PROXIMAL HUMERUS FRACTURE, A 2.5 MM DRILL BIT BROKE OFF IN THE PATIENTS HUMERUS WHILE PLACING A PROXIMAL HUMERAL PLATE AND LAST CORTICAL SCREW IN THE PLATE. THE DRILL BIT SNAPPED NEAR THE DRILL FLUTES DURING THE PREDRILLING PROCESS. THE DRILL BIT REMAINS IMPLANTED IN THE PATIENT. THE SURGEON DRILLED ANOTHER HOLE USING ANOTHER BIT TO CREATE A PILOT HOLE FOR THE FINAL CORTICAL SCREW PLACEMENT IN THE SAME COMBINATION HOLE. NO PROTRUDING WAS NOTED AND THE SURGERY WAS COMPLETED SUCCESSFULLY WITH LESS THAN 30 SECONDS DELAY IN SURGERY. NO FURTHER MEDICAL INTERVENTION WAS REQUIRED. THIS IS REPORT 1 OF 1 FOR COMPLAINT # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282614 2.5MM DRILL BIT/QC/GOLD/110MM BIT, DRILL HTW SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1