BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAG SCREW, TI 10.5X85MM

    MDR report key: 2229672 · Received July 22, 2011

    Report

    Report Number
    9610622-2011-00325
    Event Type
    Malfunction
    Date Received
    July 22, 2011
    Date of Event
    June 30, 2011
    Report Date
    June 30, 2011
    Manufacturer
    STRYKER OSTEOSYNTHESIS KIEL
    Product Code
    HSB
    PMA / PMN Number
    K032244
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DIMENSIONAL EXAMINATION REVEALED NO DEVIATIONS IN THE RELEVANT UNDAMAGED AREAS. FUNCTION TEST PERFORMED ON THE DEVICE REVEALED THAT FUNCTION IS GIVEN IN FULL. REVIEW OF DEVICE HISTORY RECORD (DHR) - A REVIEW OF THE DHR/INSPECTION RECORDS FOR THE LAG SCREW (LOT CODE K395725) REVEALED NO DISCREPANCIES. THE LOT PASSED FINAL INSPECTION IN (B)(6) 2011 IN A TOTAL QUANTITY OF 50 UNITS. THE REVIEW OF THE MANUFACTURING DOCUMENTS REVEALED NO DEVIATION DURING MANUFACTURING OF THE LAG SCREW. THE DIMENSIONAL EXAMINATION OF THE NOT DAMAGED AREAS AND THE FUNCTIONAL CHECK REVEALED THAT THE SCREW IS INTENDED CONDITION. THE EVENT IS REPRODUCIBLE IF THE WRONG CCD-ANGLE WAS CHOSEN OR IF THE SLEEVE IS NOT LOCKED ON THE TARGET DEVICE. THE EXAMINATION OF THE RETURNED LAG SCREW AND THE FUNCTIONAL CHECK REVEALED NO DEVIATION OF THE LAG SCREW. THUS, IT COULD BE ASSUMED THAT THE REPORTED EVENT IS NOT RELATED TO A DEVIATION OF THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "LAG SCREW BINDED UP WHILE INSERTING AND HAD TO BE REMOVED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAG SCREW, TI 10.5X85MM IMPLANT HSB STRYKER OSTEOSYNTHESIS KIEL NA K395725

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other