BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXFORD 4MM DRILL

    MDR report key: 3875000 · Received June 16, 2014

    Report

    Report Number
    0001825034-2014-05517
    Event Type
    Injury
    Date Received
    June 16, 2014
    Date of Event
    May 9, 2014
    Report Date
    September 4, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    NRA
    PMA / PMN Number
    PP010014
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER PRECAUTIONS, NUMBER 5 STATES, "INTRAOPERATIVE FRACTURE OR BREAKING OF INSTRUMENTS HAS BEEN REPORTED. 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 LEFT PARTIAL KNEE ARTHROPLASTY ON (B)(6) 2014. DURING THE PROCEDURE, THE DRILL BIT FRACTURED IN THE PATIENT. THE FRACTURED FRAGMENT REMAINED IN THE PATIENT'S BODY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353255 OXFORD 4MM DRILL PROSTHESIS, KNEE NRA BIOMET ORTHOPEDICS N/A 201470

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention