BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FEMORAL PLATE 6 HOLE LT

    MDR report key: 3412237 · Received October 16, 2013

    Report

    Report Number
    0001825034-2013-04611
    Event Type
    Injury
    Date Received
    October 16, 2013
    Date of Event
    September 18, 2013
    Report Date
    September 19, 2013
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    HRS
    PMA / PMN Number
    PK060969
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. (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 DISTAL FEMUR FRACTURE PROCEDURE ON (B)(6) 2013. DURING THE PROCEDURE, THE LOCKING SCREW WOULD NOT LOCK INTO THE SHAFT OF THE PLATE. SURGEON ATTEMPTED TO USE FOUR DIFFERENT SCREWS BUT WAS UNSUCCESSFUL. AS A RESULT, THE HOLE WAS MISSED AND NO SCREW WAS UTILIZED TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    529436 FEMORAL PLATE 6 HOLE LT PLATE, FIXATION, BONE HRS BIOMET ORTHOPEDICS N/A DKLBZP

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention