BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NANOFX PLEURISTIK

    MDR report key: 7114904 · Received December 13, 2017

    Report

    Report Number
    3004154314-2017-00025
    Event Type
    Malfunction
    Date Received
    December 13, 2017
    Date of Event
    November 14, 2017
    Report Date
    November 14, 2017
    Manufacturer
    ARTHROSURFACE, INC.
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXACT CAUSE FOR BREAKING OF THE NANOFX NEEDLE IS UNKNOWN. ACCORDING TO THE REP WHO ATTENDED THE CASE, THE SURGEON IS FAMILIAR WITH THE PROCEDURE AND HAS PERFORMED SEVERAL NANOFX CASES PREVIOUSLY. THE BROKEN PARTS WERE DISCARDED BY THE FACILITY. HENCE INVESTIGATION OF THE ROOT CAUSE IS NOT POSSIBLE. A REVIEW OF PREVIOUSLY LOGGED COMPLAINTS WAS PERFORMED AND NOTED THAT THIS IS THE FIRST COMPLAINT FROM THE SUSPECT LOT (LOT SIZE - 560 UNITS). ALSO, THE DHR REVIEW OF THE SUSPECT LOT WAS REVIEWED. NO NON-CONFORMITIES OR REJECTS WERE FOUND RELEVANT TO THE ISSUE. ALL TEST RESULTS (MATERIAL ANALYSIS, TENSILE STRENGTH, 100% GAUGE INSPECTION ETC.,) WITHIN THE SPECIFICATIONS AND ALL APPLICABLE STANDARDS. THIS LOT WAS MANUFACTURED IN 2015 AND SINCE HAS BEEN IN THE FIELD WITHOUT ISSUES. FINDINGS FROM PREVIOUS COMPLAINTS INDICATE QUALITY OF BONE, USE OF EXCESSIVE FORCE, WEAR ON THE GUIDE HANDLE, LACK OF THUMB TAB TO RETRACT THE NEEDLE ETC, MAY IMPACT THE FUNCTIONALITY OF THE NANOFRACTURE DEVICE. ALL BROKEN PIECES WERE RETRIEVED FROM THE PATIENT'S BONE. THERE WAS NO HARM OR INJURY TO THE USER OR TO THE PATIENT AS A RESULT OF THE REPORTED ISSUE. THE SURGEON FINISHED THE CASE USING A SECOND NANOFX NEEDLE READILY AVAILABLE WITH THE REP. WE WILL CONTINUE TO TRACK AND TREND.

    Description of Event or Problem · 1

    A NANOFX NEEDLE WAS BROKEN WHILE PERFORMING MICROFRACTURE TECHNIQUE. THE NEEDLE BROKE INTO 3 PIECES FOLLOWING THE IMPACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    891833 NANOFX PLEURISTIK ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH ARTHROSURFACE, INC. 75AE1904

    Patients

    Seq Age Sex Outcome Treatment
    1 Other