BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TARGET DEVICE 300X160MM

    MDR report key: 2072760 · Received March 31, 2011

    Report

    Report Number
    9610622-2011-00145
    Event Type
    Malfunction
    Date Received
    March 31, 2011
    Date of Event
    March 18, 2011
    Report Date
    March 18, 2011
    Manufacturer
    STRYKER OSTEOSYNTHESIS KIEL
    Product Code
    LXH
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: REVIEW OF DEVICE HISTORY RECORD (DHR) - A REVIEW OF THE INSPECTION RECORDS FOR THE TARGET DEVICE REVEALED NO DISCREPANCIES. EVAL REVEALED THE TARGET DEVICE TO BE THE PRIMARY PRODUCT. DEVIATIONS IN THE INSPECTION DOCUMENTS WERE NOT FOUND: A CHECK OF THE FUNCTION ON 100% OF THE DEVICES (SUB-SUPPLIER) AND ADD'L IN-HOUSE SPOT CHECK OF THE LOT IN QUESTION REVEALED FUNCTION WAS GIVEN IN FULL ON THE DEVICE AT THE STAGE OF DELIVERY. THE ITEM WAS DOCUMENTED AS FAULTLESS PRIOR TO DISTRIBUTION AND AS IT HAD BEEN IN USE FOR A LONGER TIME (APPROX 3 YEARS) WE PRE-SUPPOSE THAT THE TARGET DEVICE HAD FULFILLED ITS TASKS IN FORMER SURGERIES AS INTENDED. INVESTIGATION WAS NOT POSSIBLE BECAUSE THE ITEMS WILL NOT RETURN. THE CASE WAS NOT REPRODUCIBLE BY CUSTOMER. THE FILE WILL BE CLOSED FORMALLY IN ACCORDANCE TO OUR PROCEDURES. IF THE DEVICE OR ADD'L RELEVANT INFO BECOMES AVAILABLE IN FUTURE THE FILE WILL BE REVIEWED. IF THE RESULTS ARE NOT WITHIN THE POSSIBILITIES AS STATED ABOVE, THE FILE WILL BE RE-OPENED.

    Description of Event or Problem · 1

    DURING THE G3 NAIL SURGERY, THE SURGEON DRILLED THE DISTAL SCREW HOLE OF THE NAIL. HOWEVER, THE DRILL WAS CONTACTED TO THE EDGE OF DISTAL SCREW HOLE OF THE NAIL. THE SURGEON SEPARATED TIP OF DRILL SLEEVE FROM THE BONE, AND DID THE DRILLING. THE SURGEON THOUGHT THAT THERE WAS A POSSIBILITY OF NOT LOCKING DRILL SLEEVE TO TARGET DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TARGET DEVICE 300X160MM INSTRUMENT LXH STRYKER OSTEOSYNTHESIS KIEL NA KME902044

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other