BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MANUAL ORTHOPEDIC SURGICAL INSTRUMENT

    MDR report key: 7905513 · Received September 25, 2018

    Report

    Report Number
    1043534-2018-00148
    Event Type
    Injury
    Date Received
    September 25, 2018
    Date of Event
    July 26, 2018
    Report Date
    August 27, 2018
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    GAC
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    NEITHER THE DEVICE NOR APPLICABLE IMAGING FILMS WERE RETURNED TO THE MANUFACTURER FOR EVALUATION, THEREFORE, THE CAUSE OF THE EVENT CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    ALLEGEDLY, IT WAS REPORTED ON MEDWATCH MW5078900 THAT THE TIPS OF THE RASPS BROKE OFF INTO THE PATIENTS BONE DURING AN OSTEOTOMY OF THE LEFT FOOT. THE SURGEON WAS UNABLE TO REMOVE THE BROKEN PORTIONS OF THE RASP FROM THE PATIENT'S BONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    747386 MANUAL ORTHOPEDIC SURGICAL INSTRUMENT RASP, SURGICAL, GENERAL & PLASTIC SURGERY GAC WRIGHT MEDICAL TECHNOLOGY, INC. 62380110 1441712

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention