BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN FRS SYSTEM

    MDR report key: 3170679 · Received June 14, 2013

    Report

    Report Number
    0001825034-2013-01959
    Event Type
    Injury
    Date Received
    June 14, 2013
    Date of Event
    May 18, 2013
    Report Date
    May 18, 2013
    Manufacturer
    BIOMET TRAUMA
    Product Code
    HWC
    PMA / PMN Number
    PUNKNOWN
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY WAS NOT PROVIDED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A FOREFOOT TRAUMA PROCEDURE UTILIZING AN FRS SYSTEM ON (B)(6) 2013. DURING THE PROCEDURE, THE SURGEON UTILIZED A WORN SCREWDRIVER TO INSERT THREE SEPARATE SCREWS AND EACH SCREW FRACTURED DURING INSERTION. AS A RESULT, TWO SCREWS REMAIN IN THE PATIENT AND THERE WAS A GREATER THAN 30 MINUTE DELAY TO THE PROCEDURE. THE SURGEON COMPLETED THE PROCEDURE WITH DIFFERENT SCREWS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270925 UNKNOWN FRS SYSTEM SCREW, FIXATION HWC BIOMET TRAUMA N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| S