BEUDAMED
    FDA Adverse Event Other Summary report: N

    DRILL BIT DIAMETER 3.2 MM LENGTH 200 MM

    MDR report key: 3593092 · Received January 16, 2014

    Report

    Report Number
    9680825-2014-00001
    Event Type
    Other
    Date Received
    January 16, 2014
    Date of Event
    December 3, 2013
    Report Date
    January 14, 2014
    Manufacturer
    ORTHOFIX SRL
    Product Code
    JDW
    PMA / PMN Number
    K955848
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT DOES NOT MEET THE REQUIREMENTS OF MANDATORY REPORT. FOLLOWING THE INDICATIONS PROVIDED IN THE "PUBLIC HEALTH NOTIFICATION: UNRETRIEVED DEVICE FRAGMENTS" ISSUED ON JANUARY 15, 2008, ORTHOFIX SRL DECIDES TO REPORT THIS KIND OF EVENT ON A VOLUNTARY BASE. ANALYSIS OF HISTORICAL RECORDS: ORTHOFIX SRL CHECKED THE INTERNAL RECORDS RELATED TO THE CONTROLS MADE ON THE CODE 1100301, LOT NUMBER 004890 BEFORE THE MARKET RELEASE. NO ANOMALIES HAVE BEEN FOUND. THE ORIGINAL LOT, MANUFACTURED IN 2004, WAS COMPRISED OF (B)(4) DRILL BITS. ALL OF THEM HAVE ALREADY BEEN DISTRIBUTED TO THE MARKET. ACCORDING TO ORTHOFIX SRL HISTORICAL RECORDS, THIS IS THE FIRST NOTIFICATION RECEIVED FROM THIS SPECIFIC DEVICE LOT. TECHNICAL EVALUATION: THE TECHNICAL EVALUATION ON THE RETURNED DEVICE IS CURRENTLY ONGOING. MEDICAL EVALUATION: THE INFORMATION AVAILABLE ON THE CASE WAS SENT TO OUR MEDICAL EVALUATOR. A PRELIMINARY MEDICAL EVALUATION IS CURRENTLY ONGOING AND WILL BE FINALIZED ONCE THE RESULTS OF THE TECHNICAL EVALUATION WILL BE AVAILABLE. AS SOON AS THE RESULTS OF THE INVESTIGATION WILL BE AVAILABLE, ORTHOFIX SRL WILL PROVIDE YOU WITH A FOLLOW UP REPORT. ORTHOFIX SRL CONTINUES MONITORING THE DEVICES ON THE MARKET. ON (B)(6) 2014 ORTHOFIX SRL RECEIVED THE FOLLOWING INFORMATION: PATIENT'S CURRENT HEALTH CONDITION: HE IS DOING WELL. COPIES OF PRE AND POST-OPERATIVE X-RAYS: NOT AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    THE EVENT DESCRIPTION PROVIDED BY THE LOCAL DISTRIBUTOR INDICATED: HOSPITAL NAME: (B)(6) HOSPITAL, SURGEON NAME: DOCTOR (B)(6), SURGERY DESCRIPTION: CORRECTION. EVENT DESCRIPTION: THE SURGEON WOULD LIKE TO USE THE HEMICALLOTASIS DEVICE FOR THE CORRECTION OF THE LOWER EXTREMITY. S/HE WOULD LIKE TO PERFORM THE PRE-DRILLING OF THE CORTICAL BONE WITH THIS DEVICE BEFORE INSERTING HALF PIN. WHEN S/HE PULLED OUT THE DRILL BIT FROM THE BONE, THE TIP OF THE DRILL BIT WAS BROKEN AT THE 10 MM POINT FROM THE TIP. AND S/HE COULD NOT REMOVE THE TIP OF THE DRILL BIT FROM THE BONE. SO, THE BROKEN TIP OF DRILL BIT WAS LEFT IN THE PATIENT. S/HE EXPLAINED THE PRE-DRILLING IS ONLY THE CORTICAL BONE OF THE SURGEON'S SIDE. THE DEVICE FAILURE CAUSED ADVERSE EFFECTS TO PATIENT (UN-RETRIEVED DEVICE FRAGMENTS). A REPLACEMENT DEVICE WAS IMMEDIATELY AVAILABLE TO COMPLETE THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    42846 DRILL BIT DIAMETER 3.2 MM LENGTH 200 MM DRILL BIT DIAMETER 3.2 MM LENGTH 200 MM JDW ORTHOFIX SRL 1100301 004890

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR NO INFORMATION HAS BEEN MADE AVAILABLE.