BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-LINE QUICK RELEASE DRILL BIT 1/8 IN.

    MDR report key: 1933416 · Received December 20, 2010

    Report

    Report Number
    1825034-2010-00670
    Event Type
    Injury
    Date Received
    December 20, 2010
    Date of Event
    October 19, 2010
    Report Date
    November 22, 2010
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    HTW
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. THE LOT NUMBER INFORMATION NEEDED TO REVIEW DEVICE HISTORY RECORDS WAS UNAVAILABLE. THIS REPORT SUBMITTED DECEMBER 20, 2010.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A FEMORAL SIZING PROCEDURE ON (B)(6) 2010, THE TIP OF A DRILL BIT FRACTURED AND WAS RETAINED BY THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-LINE QUICK RELEASE DRILL BIT 1/8 IN. BIT, DRILL HTW BIOMET ORTHOPEDICS N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| S