BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYBRID GLENOID INSTRUMENT DRILL GUIDE ALIGNMENT PIN

    MDR report key: 2621058 · Received June 19, 2012

    Report

    Report Number
    0001825034-2012-00876
    Event Type
    Injury
    Date Received
    June 19, 2012
    Date of Event
    May 21, 2012
    Report Date
    May 25, 2012
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    IQO
    PMA / PMN Number
    PEXEMPT
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, 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 FOR RELATED IMPLANTS THAT STATES THAT THIS TYPE OF EVENT CAN OCCUR: UNDER PRECAUTIONS IT 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." THE USER FACILITY WAS NOTIFIED OF THE EVENT ON (B)(6), 2012. IN THE EVENT THAT THE USER FACILITY SUBMITS A MEDWATCH REPORT, BIOMET WILL FORWARD A COPY TO THE FDA.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT TOTAL SHOULDER ARTHROPLASTY ON (B)(6), 2012. SUBSEQUENTLY, DURING THE POST-OPERATIVE X-RAYS, IT WAS DISCOVERED THE HYBRID GLENOID DRILL GUIDE ALIGNMENT PIN WAS LEFT INSIDE OF THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYBRID GLENOID INSTRUMENT DRILL GUIDE ALIGNMENT PIN PROSTHESIS, SHOULDER IQO BIOMET ORTHOPEDICS N/A 304100

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| S