BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIAL INSERT J 32MM SYM.

    MDR report key: 5112437 · Received September 29, 2015

    Report

    Report Number
    3005673311-2015-00137
    Event Type
    Malfunction
    Date Received
    September 29, 2015
    Report Date
    February 23, 2016
    Manufacturer
    AESCULAP IMPLANT SYSTEMS
    Product Code
    HWT
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURING SITE EVALUATION: SAMPLES RECEIVED: 8 TRAIL INSERTS WERE PROVIDED FOR INVESTIGATION. ANALYSIS AND RESULTS: THE TRIAL INSERTS SHOW SEVERAL DAMAGES AROUND THE LONG HOLES, WHICH APPEAR TO HAVE OCCURRED DUE TO INCORRECT PLACEMENT OF THE FORCEPS. THE FORCEPS MAY HAVE SLIPPED OUT OF THE LONG HOLES LEAVING THE DAMAGE. THERE ARE NO OTHER COMPLAINTS ON FILE FOR THIS PRODUCT/ISSUE, THEREFORE A SYSTEMATICAL ERROR IN MANUFACTURING AND IN MATERIALS HAS BEEN EXCLUDED. FINAL CONCLUSION: COMPLAINT IS NOT JUSTIFIED. THE FAILURE IS USER RELATED. CORRECTIVE/PREVENTIVE ACTIONS: THERE ARE NO SAFETY PROBLEM AND ALL THE REGULATORY REQUIREMENTS HAVE BEEN MET.

    Description of Event or Problem · 1

    INTRA-OPERATIVE FEATHERING BURR IN LONG HOLE WHEN APPLYING WITH FORCEPS AND FRAGMENTS WERE BREAKING OFF; FRAGMENTS MAY REMAIN IN THE PATIENT. NO HARM TO THE PATIENT; NO DELAY TO PROCEDURE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    641946 TRIAL INSERT J 32MM SYM. INSTRUMENT FOR HIP ENDOPROSTHESIS SURGERY HWT AESCULAP IMPLANT SYSTEMS NT506

    Patients

    Seq Age Sex Outcome Treatment
    1 Other