BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KEYED LAG SCREW-STD 90MM

    MDR report key: 3935054 · Received July 15, 2014

    Report

    Report Number
    0001825034-2014-06166
    Event Type
    Malfunction
    Date Received
    July 15, 2014
    Date of Event
    April 28, 2014
    Report Date
    June 20, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KTT
    PMA / PMN Number
    PK972629
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    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. EXAMINATION OF RETURNED DEVICE FOUND EVIDENCE OF PRODUCT NON-CONFORMANCE. CORRECTIVE ACTIONS HAVE BEEN INITIATED TO ADDRESS THE REPORTED ISSUE. (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 RIGHT HIP OPEN REDUCTION INTERNAL FIXATION PROCEDURE ON (B)(6) 2014. DURING THE PROCEDURE, IT WAS NOTED THE TK2 LAG SCREW WAS NOT KEYED. ANOTHER TK2 LAG SCREW WAS UTILIZED TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    412784 KEYED LAG SCREW-STD 90MM APPLIANCE, FIXATION KTT BIOMET ORTHOPEDICS N/A DLLCND

    Patients

    Seq Age Sex Outcome Treatment
    1