BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAIL ATTACHMENT ROD

    MDR report key: 2969784 · Received February 13, 2013

    Report

    Report Number
    9680825-2013-00003
    Event Type
    Malfunction
    Date Received
    February 13, 2013
    Date of Event
    December 9, 2012
    Report Date
    February 13, 2013
    Manufacturer
    ORTHOFIX SRL
    Product Code
    HSB
    PMA / PMN Number
    K053261
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF HISTORICAL RECORDS: ORTHOFIX SRL CHECKED THE INTERNAL RECORDS RELATED TO THE CONTROLS MADE ON THIS SPECIFIC LOT BEFORE THE MARKET RELEASE. NO ANOMALIES HAVE BEEN FOUND. THE ORIGINAL LOT, MFG IN 2011, WAS COMPRISED OF (B)(4) DEVICES. ALL OF THEM HAVE ALREADY BEEN DISTRIBUTED TO THE MARKET. ACCORDING TO ORTHOFIX SRL HISTORICAL RECORDS, THIS IS THE FIRST BREAKAGE NOTIFIED FROM THIS SPECIFIC DEVICE CODE. TECHNICAL EVAL: THE TECHNICAL EVAL ON THE RETURNED DEVICE IS CURRENTLY ON GOING. CLINICAL EVAL: THE INFO AVAILABLE ON THE CASE WAS SENT TO OUR MEDICAL EVALUATOR. A PRELIMINARY CLINICAL EVAL WAS PERFORMED AND WILL BE FINALIZED ONCE THE RESULTS OF THE TECHNICAL EVAL WILL BE AVAILABLE. AS SOON AS THE RESULTS OF THE INVESTIGATION WILL BE AVAILABLE, ORTHOFIX SRL WILL PROVIDE YOU WITH A F/U REPORT. ORTHOFIX SRL CONTINUES MONITORING THE DEVICES ON THE MARKET.

    Description of Event or Problem · 1

    THE INFO PROVIDED BY THE DISTRIBUTOR INDICATES: HOSPITAL NAME: (B)(6). SURGEON NAME: DR (B)(6). DATE OF SURGERY: (B)(6) 2012. BODY PART TO WHICH DEVICE WAS APPLIED: ANKLE. EVENT DESCRIPTION: DURING SURGERY, TIBIOTALAR CALCANEAL FUSION WITH ANKLE COMPRESSION NAIL FOLLOWING GRADE IIIA OPEN LEFT DISTAL TIBIA AND FIBULA FRACTURE, THE DISTAL THREADS OF THE DEVICE CODE 177110 BROKE OFF IN THE NAIL. THE SURGEON WAS NOT ABLE TO RETRIEVE THIS SMALL THREAD. LATEST F/U ((B)(6) 2013) DESCRIBES PT DOING VERY WELL. ON (B)(6) 2013 ORTHOFIX SRL RECEIVED A COPY OF THE OPERATIVE REPORT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    63944 NAIL ATTACHMENT ROD NAIL ATTACHMENT ROD HSB ORTHOFIX SRL 177110 25902A

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR NO INFO HAS BEEN MADE AVAILABLE.