BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.0/2.5MM DRIVER BIT

    MDR report key: 4110815 · Received September 23, 2014

    Report

    Report Number
    0001825034-2014-07807
    Event Type
    Injury
    Date Received
    September 23, 2014
    Date of Event
    August 23, 2014
    Report Date
    August 26, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    HTW
    PMA / PMN Number
    PEXEMPT
    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. THE FOLLOWING SECTIONS COULD NOT BE COMPLETED WITH THE LIMITED INFORMATION PROVIDED. LOT NUMBER - UNKNOWN; INITIAL REPORTER - UNKNOWN; MANUFACTURE DATE ¿ UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT AN ALPS HAND PROCEDURE ON (B)(6) 2014. DURING THE PROCEDURE, TWO DRIVERS FRACTURED. ONE DRIVER WOULD NOT EASILY GO THROUGH THE PLATE GUIDE, AND ON CLOSER INSPECTION, IT WAS TWISTED AND BENT. THE V-TIP OF THE SECOND DRIVER CAME OFF INTO THE SCREW HEAD. THE SCREW AND V-TIP WERE REMOVED AND THE PROCEDURE WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    590453 2.0/2.5MM DRIVER BIT BIT, DRILL HTW BIOMET ORTHOPEDICS N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention