BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOTAL HIP MODULAR FLEX DRILL BIT

    MDR report key: 2182615 · Received July 5, 2011

    Report

    Report Number
    1822565-2011-01584
    Event Type
    Malfunction
    Date Received
    July 5, 2011
    Date of Event
    May 17, 2011
    Report Date
    June 7, 2011
    Manufacturer
    ZIMMER INC
    Product Code
    HTW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: IT IS UNKNOWN IF A DRILL GUIDE WAS USED WHEN DRILLING THE SCREW HOLE. THE PT'S BONE QUALITY IS ALSO UNKNOWN. A DRILL BIT FRACTURE CAN BE CAUSED BY ONE OR MORE OF THE FOLLOWING. EXCESSIVE FORCE APPLIED DURING USAGE. CONTINUED OPERATION OF THE DRILL AFTER IT WAS STUCK AGAINST HARD MATERIAL. RAPID REVERSAL OF DIRECTION OF ROTATION WHEN THE DEVICE IS STUCK. EXCESSIVE BENDING. DEVICE WEAR DUE TO USAGE WITH TIME. LOW SPEED / HIGH TORQUE OF OPERATION. BASED ON THE INFO PROVIDED, A DEFINITIVE CAUSE FOR THE FRACTURE CANNOT BE DETERMINED WITH CERTAINTY. THE DIMENSIONS THAT WERE MEASURED ON THE RETURNED PARTS WERE CONFORMING TO SPECIFICATIONS. THE DEVICE HISTORY RECORD WAS REVIEWED AND FOUND TO BE CONFORMING TO THE MANUFACTURING, INSPECTION, AND PACKAGING SPECIFICATIONS.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE TWO DRILL BITS FRACTURED DURING USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TOTAL HIP MODULAR FLEX DRILL BIT HTW ZIMMER INC 61752779

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR TOTAL HIP MODULAR FLEX DRILL BIT| CATALOG #00879000703, LOT #61574004