BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRA DRIVE 7MM DISK DRILL

    MDR report key: 2894718 · Received January 3, 2013

    Report

    Report Number
    0001825034-2013-00014
    Event Type
    Injury
    Date Received
    January 3, 2013
    Date of Event
    November 29, 2012
    Report Date
    December 10, 2012
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JXE
    PMA / PMN Number
    PK031280
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. DIMENSIONAL EVALUATION FOUND COMPONENT TO BE WITHIN APPROPRIATE DESIGN SPECIFICATION.

    Additional Manufacturer Narrative · 1

    THE USER FACILITY IS OUTSIDE OF THE UNITED STATES. NO MEDWATCH REPORT WAS RECEIVED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER WARNINGS, NUMBER 1 STATES, "THE SURGEON IS TO BE THOROUGHLY FAMILIAR WITH THE EQUIPMENT AND THE SURGICAL PROCEDURE PRIOR TO PERFORMING SURGERY."

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A SHOULDER PROCEDURE ON (B)(6) 2012, UTILIZING AN ULTRA DRIVE DISC DRILL. THE DISC DRILL FRACTURED DURING USE AND WAS RETRIEVED FROM THE WOUND. ANOTHER ULTRA DRIVE DISC DRILL WAS USED TO FINISH THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3659 ULTRA DRIVE 7MM DISK DRILL DEVICE JXE BIOMET ORTHOPEDICS N/A 891890

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention