BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPACTION TOOL

    MDR report key: 3901521 · Received June 30, 2014

    Report

    Report Number
    0001825034-2014-05846
    Event Type
    Malfunction
    Date Received
    June 30, 2014
    Date of Event
    May 31, 2013
    Report Date
    June 14, 2013
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    HWA
    PMA / PMN Number
    PEXEMPT
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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. EXPIRATION DATE & LOT NUMBER - UNKNOWN; MANUFACTURE DATE ¿ UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT AN AFFIXUS SHORT HIP NAIL PROCEDURE ON (B)(6) 2013. DURING THE PROCEDURE, THE IMPACTION TOOL FRACTURED WHILE IMPACTING THE NAIL. ANOTHER INSTRUMENT WAS UTILIZED TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379511 IMPACTION TOOL IMPACTOR HWA BIOMET ORTHOPEDICS N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1