BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WIRE FX BOLT SLOTTED SS

    MDR report key: 3286012 · Received August 14, 2013

    Report

    Report Number
    0001825034-2013-03179
    Event Type
    Malfunction
    Date Received
    August 14, 2013
    Date of Event
    April 17, 2013
    Report Date
    July 15, 2013
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KTT
    PMA / PMN Number
    PK112218
    Removal / Correction Number
    Z-0508-2012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER ASSOCIATED WITH THIS MEDWATCH WAS MANUFACTURED BY DEPUY ORTHOPEDICS. DEPUY ORTHOPEDICS MADE A DECISION TO RECALL THE LOT BASED ON MANUFACTURING ISSUES THAT WERE DETERMINED AS PART OF AN INTERNAL INVESTIGATION. REFERENCE Z-0508-2012. THIS REPORT IS NUMBER 2 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2013-03167 & 03179). (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 THAT PATIENT UNDERWENT A FLAT FOOT RECONSTRUCTION ON (B)(6) 2013. DURING THE PROCEDURE, THE BOLT/NUT COMBINATION CROSS THREADED MULTIPLE TIMES AND AS A RESULT, THE BOLT HAD TO BE CUT OFF. THE SURGEON COMPLETED THE PROCEDURE WITH AN ACE FISHER FRAME, ALPS TOTAL FOOT SYSTEM AND BIODRIVE SCREWS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    391923 WIRE FX BOLT SLOTTED SS APPLIANCE, FIXATION KTT BIOMET ORTHOPEDICS N/A 570133

    Patients

    Seq Age Sex Outcome Treatment
    1