BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PEG STANDARD 4.0X45.0MM

    MDR report key: 3307288 · Received August 26, 2013

    Report

    Report Number
    0001825034-2013-03387
    Event Type
    Injury
    Date Received
    August 26, 2013
    Date of Event
    July 25, 2013
    Report Date
    July 30, 2013
    Manufacturer
    BIOMET
    Product Code
    HRS
    PMA / PMN Number
    PK111663
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    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 - UNKNOWN. MANUFACTURE DATE ¿ UNKNOWN. (NOTE: BIOMET, INC. ACQUIRED THE TRAUMA PRODUCT LINE FROM DEPUY ORTHOPAEDICS, INC. (¿DEPUY¿) ON JUNE 16, 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.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A PROXIMAL HUMERUS ORIF PROCEDURE ON (B)(6) 2013. DURING THE PROCEDURE, SURGEON ATTEMPTED MULTIPLE TIMES TO DRILL AND LOCK THE PEG INTO THE PLATE WITHOUT SUCCESS. AS A RESULT, A S3 PROXIMAL HUMERAL PLATE WAS UTILIZED TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    415426 PEG STANDARD 4.0X45.0MM PLATE, FIXATION HRS BIOMET N/A 333333

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention