BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OXFORD UNI KNEE PHASE III 4.0MM DIAM. FEMORAL DRILL

    MDR report key: 1542200 · Received November 20, 2009

    Report

    Report Number
    1825034-2009-00300
    Event Type
    Malfunction
    Date Received
    November 20, 2009
    Date of Event
    October 20, 2009
    Report Date
    October 27, 2009
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    HTW
    PMA / PMN Number
    P010014
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PMA/510(K) NUMBER - WAS ORIGINALLY REPORTED EXEMPT DUE TO THE COMPONENT BEING AN INSTRUMENT, HOWEVER, THE DEVICE IS LISTED WITH A PMA NUMBER OF P010014.

    Additional Manufacturer Narrative · 1

    REVIEW OF MATERIAL CERTIFICATION AND DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. EVALUATION OF THE RETURNED DEVICE FOUND EVIDENCE OF BRITTLE FRACTURE DUE TO BEND OVERLOAD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A KNEE PROCEDURE UTILIZING A FEMORAL DRILL ON (B) (6) 2009. DURING THE PROCEDURE, THE DRILL BIT FRACTURED WHILE BEING DRILLED AGGRESSIVELY. THE DRILL BIT FRAGMENT WAS REMOVED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO ADVERSE OUTCOME TO THE PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A KNEE PROCEDURE UTILIZING A FEMORAL DRILL ON (B) (6) 2009. DURING THE PROCEDURE, THE DRILL BIT FRACTURED WHILE BEING DRILLED AGGRESSIVELY. THE DRILL BIT FRAGMENT WAS REMOVED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO ADVERSE OUTCOME TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OXFORD UNI KNEE PHASE III 4.0MM DIAM. FEMORAL DRILL DRILL BIT HTW BIOMET ORTHOPEDICS N/A 657860

    Patients

    Seq Age Sex Outcome Treatment
    1