BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G&K FEM NAIL EXTRACTION

    MDR report key: 5971760 · Received September 22, 2016

    Report

    Report Number
    0009610622-2016-00443
    Event Type
    Malfunction
    Date Received
    September 22, 2016
    Date of Event
    August 26, 2016
    Report Date
    August 26, 2016
    Manufacturer
    STRYKER TRAUMA KIEL
    Product Code
    HSB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WILL NOT BE RETURNED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT. DEVICE DISPOSITION IS UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT THE SURGERY WITH THE AP-J NAIL. ON (B)(6) 2016, THE PATIENT UNDERWENT THE AP-J EXTRACT SURGERY DUE TO OSTEOARTHRITIS AND TO CONVERT TO THA. THE SURGEON USED THE EXTRACTION ADAPTER FOR AP-J. HOWEVER THE SURGEON DID NOT EXTRACTED THE NAIL. WHEN THE SURGEON CHECKED THE ADAPTER, HE FOUND THAT IT IS ANOTHER ADAPTER (1111-1100). THEREFORE THE SURGEON USED THE ADAPTER FOR GAMMA3. HE EXTRACTED THE NAIL AND CANCELED THA. THIS ADAPTER WAS SHIPPED FROM OUR DISTRIBUTION CENTER. THA WAS CANCELLED BECAUSE THE NAIL REMOVAL TOOK TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    623512 G&K FEM NAIL EXTRACTION INSTRUMENT HSB STRYKER TRAUMA KIEL UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other