BEUDAMED
    FDA Adverse Event Other Summary report: N

    GMK FEMORAL CUTTING GUIDE 4INL SIZE 4

    MDR report key: 3723689 · Received December 19, 2013

    Report

    Report Number
    3005180920-2013-00178
    Event Type
    Other
    Date Received
    December 19, 2013
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FROM THE DOCUMENT REVIEW OF THE LOT INVOLVED (1112890 - (B)(4) ITEMS PRODUCED) NO ANOMALIES WERE FOUND. THE CUTTING GUIDE AND THE (B)(4) PINS RETURNED BACK TO MEDACTA AND WERE INSPECTED BY QC DEPT WITH THE FOLLOWING RESULTS: THE CUTTING GUIDE DOES NOT PRESENT EVIDENCES OF WEAR AND ALL THE FIXATION HOLES ARE FUNCTIONING, W/O METALLIC FRAGMENTS. THE PINS HAVE A FEW SUPERFICIAL SCRATCHES CAUSED BY NORMAL USE BUT THERE IS NO DETACHMENT OF MATERIAL AND RESULTING TO BE FUNCTIONING. THE ONLY POSSIBLE EXPLANATION IS THAT THE FRAGMENTS CAME FROM THE THREADED DRILL USED TO PERFORM THE PRELIMINARY HOLES PRIOR TO FIX THE PINS.

    Description of Event or Problem · 1

    REF IMP # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    666272 GMK FEMORAL CUTTING GUIDE 4INL SIZE 4 REUSABLE SURGICAL INSTRUMENT FOR KNEE LZO MEDACTA INTERNATIONAL SA

    Patients

    Seq Age Sex Outcome Treatment
    1