BEUDAMED
    FDA Adverse Event Other Summary report: N

    THREADED WIRE

    MDR report key: 3471757 · Received November 4, 2013

    Report

    Report Number
    9680825-2013-00026
    Event Type
    Other
    Date Received
    November 4, 2013
    Date of Event
    October 1, 2013
    Report Date
    October 28, 2013
    Manufacturer
    ORTHOFIX SRL
    Product Code
    KTT
    PMA / PMN Number
    K113770
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT DOES NOT MEET THE REQUIREMENTS OF MANDATORY REPORT, AS THERE ARE NO ADVERSE EFFECTS TO PT. FOLLOWING THE INDICATIONS PROVIDED IN THE "PUBLIC HEALTH REQUIREMENTS: 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 93100 LOT NUMBER G030 BEFORE THE MARKET RELEASE. NO ANOMALIES HAVE BEEN FOUND. THE ORIGINAL LOT, MANUFACTURED IN (B)(4) 2013, WAS COMPRISED OF 340 WIRES. (B)(4) HAVE ALREADY BEEN DISTRIBUTED TO THE MARKET. ACCORDING TO ORTHOFIX SRL HISTORICAL RECORDS, THIS IS THE FIRST NOTIFICATION RECEIVED FROM THIS SPECIFIC DEVICE CODE AND LOT. TECHNICAL EVALUATION: THE TECHNICAL EVALUATION ON THE RETURNED DEVICE IS CURRENTLY ON GOING. CLINICAL EVALUATION: THE INFORMATION AVAILABLE ON THE CASE WAS SENT TO OUR MEDICAL EVALUATOR. A PRELIMINARY CLINICAL 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.

    Description of Event or Problem · 1

    THE EVENT DESCRIPTION PROVIDED BY THE LOCAL AGENT INDICATED: (B)(6): HUMERAL HEAD FRACTURE TREATMENT. EVENT DESCRIPTION: DURING THE APPLICATION IN THE OPERATIVE ROOM, THE THREADED WIRE BROKE. NO ADVERSE EFFECTS TO PT; THE TIP OF THE DEVICE WAS LEFT IN PT BONE; THE EVENT LED TO A CLINICALLY RELEVANT PROLONGATION OF THE SURGICAL PROCEDURE. THE PT IS IN GOOD HEALTH CONDITION. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    567032 THREADED WIRE THREADED WIRE KTT ORTHOFIX SRL 93100 G030

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR NO INFORMATION HAS BEEN MADE AVAILABLE