BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREWDRIVER HEX BALL END 3.5MM

    MDR report key: 2974453 · Received February 22, 2013

    Report

    Report Number
    0001825034-2013-00327
    Event Type
    Injury
    Date Received
    February 22, 2013
    Report Date
    January 28, 2013
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    HXX
    PMA / PMN Number
    PEXEMPT
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DIMENSIONAL EVALUATION FOUND COMPONENT TO BE WITHIN APPROPRIATE DESIGN SPECIFICATION. EVALUATION OF RETURNED DEVICE FOUND EVIDENCE THAT INSTRUMENT FRACTURED DUE TO TORQUE OVERLOAD. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER PRECAUTIONS IT STATES, "SURGICAL INSTRUMENTS ARE SUBJECT TO WEAR WITH NORMAL USAGE. INSTRUMENTS, WHICH HAVE EXPERIENCED EXTENSIVE USE OR EXCESSIVE FORCE, ARE SUSCEPTIBLE TO FRACTURE. SURGICAL INSTRUMENTS SHOULD ONLY BE USED FOR THEIR INTENDED PURPOSE. BIOMET RECOMMENDS THAT ALL INSTRUMENTS BE REGULARLY INSPECTED FOR WEAR AND DISFIGUREMENT. "

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A REVISION OF COMPETITOR'S PRODUCTS ON AND UNKNOWN DATE. DURING THE REVISION, WHEN THE SURGEON WAS TIGHTENING AND AUGMENT SCREW, THE BALLPOINT TIP OF THE SCREWDRIVER FRACTURED OFF. AS A RESULT, THE TIP REMAINED IN THE SCREW WHICH WAS COVERED WITH BONE CEMENT AND REMAINS IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78066 SCREWDRIVER HEX BALL END 3.5MM SCREWDRIVER HXX BIOMET ORTHOPEDICS N/A 392270

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| S