BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4.75 FIXD NON-LCKNG SCRW 20MM

    MDR report key: 2833447 · Received November 15, 2012

    Report

    Report Number
    0001825034-2012-02433
    Event Type
    Injury
    Date Received
    November 15, 2012
    Date of Event
    October 24, 2012
    Report Date
    October 24, 2012
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    HWC
    PMA / PMN Number
    PUNKNOWN
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. THE FOLLOWING SECTIONS COULD NOT BE COMPLETED WITH THE LIMITED INFORMATION PROVIDED. PRODUCT CODE - UNKNOWN. PRODUCT IDENTIFICATION & EXPIRATION DATE - UNKNOWN. MANUFACTURE DATE - UNKNOWN. THE PRODUCT IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY WAS NOT PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT TOTAL SHOULDER ARTHROPLASTY ON (B)(6) 2012. WHILE SURGEON WAS INSERTING A SCREW IT FRACTURED. SURGEON WAS UNABLE TO RETRIEVE, THEREFORE REMAINED IN PATIENT . A SECOND SCREW WAS ATTEMPTED AND STRIPPED CAUSING THE SURGEON TO REMOVE WITH REMOVAL KIT. ANOTHER SCREW WAS USED TO FINISH THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 4.75 FIXD NON-LCKNG SCRW 20MM PROSTHESIS, SHOULDER HWC BIOMET ORTHOPEDICS N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R| S