BEUDAMED
    FDA Adverse Event Other Summary report: N

    XCALIBER OSTEOTITE BONE SCREWS

    MDR report key: 1566379 · Received September 22, 2009

    Report

    Report Number
    9680825-2009-00002
    Event Type
    Other
    Date Received
    September 22, 2009
    Date of Event
    September 8, 2009
    Report Date
    December 22, 2009
    Manufacturer
    ORTHOFIX SRL
    Product Code
    HWC
    PMA / PMN Number
    K995848
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT DOES NOT MEET THE REQUIREMENTS OF MANDATORY REPORTING. FOLLOWING THE INDICATIONS PROVIDED IN THE "PUBLIC HEALTH NOTIFICATION: UNRETRIEVED DEVICE FRAGMENTS" ISSUES ON (B)(4), 2008, ORTHOFIX SRL DECIDES TO REPORT THIS KIND OF EVENTS, ON A VOLUNTARY BASE. THE DEVICE WAS SUBJECT TO CHEMICAL, MECHANICAL METALLURGICAL AND FAILURE ANALYSIS. TECHNICAL ANALYSIS PERFORMED ON THE SCREW SHOWED IT TO BE CONFORMING TO ORTHOFIX PRODUCT SPECIFICATIONS. THE BREAKAGE OCCURRED DUE TO TORSIONAL OVERLOAD. THE BREAKAGE IS NOT RELATED TO THE PRODUCT BUT IT IS DUE TO MECHANICAL LOADS APPLIED. ACCORDING TO THE INFO PROVIDED REGARDING THIS CASE AND AS RESULT OF THE INVESTIGATION PERFORMED, ORTHOFIX CONCLUDES THAT THE SCREW WAS SUBJECT TO TORSIONAL OVERLOAD DURING INSERTION WHICH CAUSED IT TO BREAK. ORTHOFIX WOULD LIKE TO EMPHASIZE ONCE MORE THE IMPORTANCE OF METICULOUSLY FOLLOWING THE INSTRUCTIONS FOR USE FOR A CORRECT APPLICATION (REF. TO PQEXEF, WARNING 13), WHERE DETAILED INFO ARE REPORTED REGARDING SCREW SELECTION AND THE CORRECT INSERTION TECHNIQUE. (B)(4).

    Description of Event or Problem · 1

    THE BROKEN PART OF A SCREW WAS LEFT IN PT TIBIA. THE PT DID NOT HAVE ANY ADVERSE EFFECTS RELATED TO THE SCREW BREAKAGE. MANUFACTURER REFERENCE NUMBERS: ORTHOFIX SRL COMPLAINT NUMBER (B)(4). ORTHOFIX INC COMPLAINT NUMBER (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XCALIBER OSTEOTITE BONE SCREWS XCALIBER OSTEOTITE BONE SCREWS HWC ORTHOFIX SRL 611530 10660860

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR