BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5.0MM TRANSPEDICULAR SCHANZ SCREW

    MDR report key: 3161315 · Received June 11, 2013

    Report

    Report Number
    2520274-2013-03144
    Event Type
    Malfunction
    Date Received
    June 11, 2013
    Date of Event
    February 14, 2011
    Report Date
    July 8, 2011
    Manufacturer
    SYNTHES USA
    Product Code
    NKB
    PMA / PMN Number
    K082572
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. A REVIEW OF THE DEVICE HISTORY RECORDS WAS NOT PERFORMED BECAUSE NO LOT NUMBER WAS PROVIDED. THE ADDITIONAL EVALUATION REVEALED THAT THE FRACTURE SURFACES OF THE SCREWS A AND B SCREWS WERE CHECKED AND THE INITIAL FRACTURE AREAS AND THE FRACTURE BEHAVIOR COULD BE IDENTIFIED. THE EXAMINATION OF THE FRACTURE SURFACES INDICATE THAT THE SCREWS FAILED BECAUSE OF FATIGUE AND OVERLOAD. APPROXIMATELY 5 TO 10 PERCENT OF THE FRACTURE SURFACES OF THE INVESTIGATED SCREWS ARE CHARACTERIZED BY A MIXED FRACTURE WITH FATIGUE STRIATIONS AND A STRUCTURAL FRACTURE APPEARANCE AT THE INITIAL FRACTURE ZONES. THE FORCED FRACTURE PARTS OF THE FRACTURE SURFACES CORRESPOND TO THE RESIDUAL FRACTURE ZONE. THE FAILURE OF THE INVESTIGATED SCREWS WAS DUE TO DYNAMIC BENDING -DOUBLE SIDED- WHICH LED TO OVERLOAD AND MATERIAL FATIGUE. BASED ON THE TOPOGRAPHY OF THE FRACTURE SURFACES IT CAN CONCLUDED THAT THE INVESTIGATED SCREWS HAD TO ABSORB AND NEUTRALIZE FORCES THAT MAY HAVE BEEN GREATER THAN THE TOLERABLE LOAD. POSTOPERATIVE ACTIVITIES OF THE PATIENT MAY HAVE PLAYED A CERTAIN ROLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN EXPLANTING PROCEDURE THE SURGEON DISCOVERED THAT TWO OUT OF FOUR SCREWS WERE BROKEN. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    263313 5.0MM TRANSPEDICULAR SCHANZ SCREW NKB SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 50