BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOCKING SCREW, FULLY THREADED 5X45 MM

    MDR report key: 1520885 · Received October 30, 2009

    Report

    Report Number
    9610622-2009-00365
    Event Type
    Malfunction
    Date Received
    October 30, 2009
    Date of Event
    October 8, 2009
    Report Date
    October 8, 2009
    Manufacturer
    STRYKER OSTEOSYNTHESIS KIEL
    Product Code
    HSB
    PMA / PMN Number
    K003018
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER RECEIVED BOTH, LOCKING SCREWS, CAT. #18965045S, LOT CODE K231754 AS WELL AS LOCKING SCREWS, CAT. #18964045S, LOT CODE K214566. THE SALES REP INDICATED THE BLISTER LABELED CAT. #18965045S, LOT CODE K231754 WAS PREVIOUSLY OPENED AND HE REPLIED THAT THE CUSTOMER REPORTED THAT BOTH THE OUTER PACKAGING AND BLISTER (LABELED 18965045S, LOT CODE K231754 CONTAINING ITEM CAT. #18964045S) WERE OPENED DURING THE SURGERY. DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, IT WILL BE REPORTED ON A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THE MEDICAL DEVICE SERVICE REP, REFERRED TO THE SALES REP THAT: DURING THE SURGERY, THE SURGEON TOOK THE SCREW TO INSERT IT INTO THE HOLE PRACTICED ON THE BONE AND REALIZED THAT THE SCREW WAS SMALLER THAN THE SIZE IT SHOULD HAVE BEEN. AT THAT POINT, THE OPERATING ROOM NURSE NOTICED THAT THE CODE AND LOT BOTH INDICATED ON THE PACKAGE AND ON THE BLISTER (5 X 45) WERE DIFFERENT FROM THE ONES INDICATED IN THE PATIENT RECORD LABELS (4 X 45). TO END THE SURGERY, THE SURGEON USED ANOTHER SCREW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LOCKING SCREW, FULLY THREADED 5X45 MM IMPLANT HSB STRYKER OSTEOSYNTHESIS KIEL NA K231754

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other