BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MILTEX MALLET 11 16OZ

    MDR report key: 5226730 · Received November 16, 2015

    Report

    Report Number
    2523190-2015-00121
    Event Type
    Malfunction
    Date Received
    November 16, 2015
    Report Date
    November 3, 2015
    Manufacturer
    INTEGRA YORK, PA INC.
    Product Code
    GFJ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON 12/14/2015 INTEGRA INVESTIGATION COMPLETED. METHOD: FAILURE ANALYSIS, DEVICE HISTORY EVALUATION. RESULTS: FAILURE ANALYSIS: A MALLET RETURNED IN USED CONDITION, WITH (B)(6) 2015 ETCHED INTO HANDLE. IT IS NOTICED THERE ARE SCRATCHES AND DENTS OF VARYING DEGREES ON THE MALLET. EVALUATION OF THE MALLET SHOWS THAT THE HEAD IS SECURELY ATTACHED TO THE HANDLE AND THE WELD IS STILL INTACT. . DUE TO THE WEAR, TEAR OF THE MALLET AND UNABLE TO CONFIRM REPORT. THE COMPLAINT IS UNCONFIRMED; UNABLE TO CONFIRM REPORT. DEVICE HISTORY EVALUATION - NONCONFORMING PRODUCT REPORT / NONCONFORMING MATERIAL REPORT HISTORY: THERE IS NO APPLICABLE NONCONFORMING PRODUCT REPORT / NONCONFORMING MATERIAL REPORT HISTORY. VARIANCE AUTHORIZATION / DEVIATION HISTORY: THERE IS NO APPLICABLE VARIANCE AUTHORIZATION / DEVIATION HISTORY ENGINEERING CHANGE ORDER/MANUFACTURING CHANGE ORDER HISTORY: THERE IS NO APPLICABLE ENGINEERING CHANGE ORDER/MANUFACTURING CHANGE ORDER HISTORY. CORRECTIVE ACTION PREVENTIVE ACTION HISTORY: THERE IS NO APPLICABLE CORRECTIVE ACTION PREVENTIVE ACTION HISTORY. HEALTH HAZARD EVALUATION HISTORY: NONE. CONCLUSION: THE COMPLAINT IS UNCONFIRMED; UNABLE TO CONFIRM REPORT.

    Additional Manufacturer Narrative · 1

    TO DATE THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    CUSTOMER INITIALLY REPORTS DEVICE IS DEFECTIVE. ON (B)(6) 2015 CUSTOMER REPORTS THE HEAD OF MALLET BROKE OFF IN USE. NO ONE HURT AT THIS TIME BUT FEAR THAT COULD HAPPEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    758383 MILTEX MALLET 11 16OZ M10 - ORTHOPEDIC GFJ INTEGRA YORK, PA INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1