BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NON LOCK SCREW 1.5X22MM

    MDR report key: 2898204 · Received January 7, 2013

    Report

    Report Number
    0001825034-2013-00028
    Event Type
    Injury
    Date Received
    January 7, 2013
    Date of Event
    December 12, 2012
    Report Date
    December 13, 2012
    Manufacturer
    BIOMET TRAUMA
    Product Code
    HRS
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LOT NUMBER & EXPIRATION DATE - UNKNOWN MANUFACTURE DATE - UNKNOWN THE PRODUCT IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY WAS NOT PROVIDED. EVALUATION IN PROCESS BUT NOT YET COMPLETE. UPON COMPLETION OF EVALUATION, A FOLLOW UP REPORT WILL BE SENT TO THE FDA. (NOTE: BIOMET, INC. ACQUIRED THE TRAUMA PRODUCT LINE FROM DEPUY ORTHOPAEDICS, INC. ("DEPUY") ON (B)(4) 2012 ("CLOSING DATE"). PURSUANT TO THE WRITTEN AGREEMENT BETWEEN BIOMET AND DEPUY, BIOMET AGREED TO BE RESPONSIBLE FOR REGULATORY REPORTING FOR EVENTS WHICH OCCURRED AFTER THE CLOSING DATE REGARDLESS OF THE ENTITY THAT ACTUALLY MANUFACTURED THE PRODUCT OR ACTUALLY SOLD THE PRODUCT TO THE HEALTHCARE PROVIDER. BECAUSE THE PRODUCT THAT IS THE SUBJECT MATTER WAS MANUFACTURED BEFORE THE CLOSING DATE, PLEASE BE ADVISED THAT THE SUBJECT PRODUCT WAS MANUFACTURED BY DEPUY AND NOT BIOMET.) DEPUY ALSO SOLD THE PRODUCT THAT IS THE SUBJECT MATTER TO THE HEALTHCARE PROVIDER INVOLVED.

    Additional Manufacturer Narrative · 1

    EVALUATION OF DEVICE FOUND EVIDENCE THAT FAILURE MODE WAS DUE TO TORSIONAL OVERLOAD.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT PROXIMAL RADIUS PROCEDURE (B)(6) 2012, UTILIZING A NON LOCKING SCREW. WHEN SURGEON ATTEMPTED TO BACK OUT THE SCREW, THE HEAD FRACTURED OFF. A PORTION OF THE SCREW WAS RETAINED IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    7456 NON LOCK SCREW 1.5X22MM PLATE, FIXATION HRS BIOMET TRAUMA N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability