BEUDAMED
    FDA Adverse Event Other Summary report: N

    OSTEOTITE CORTICAL SCREW, STERILE

    MDR report key: 1785047 · Received March 4, 2010

    Report

    Report Number
    9680825-2010-00003
    Event Type
    Other
    Date Received
    March 4, 2010
    Date of Event
    January 19, 2010
    Report Date
    March 4, 2010
    Manufacturer
    ORTHOFIX SRL
    Product Code
    JDW
    PMA / PMN Number
    K974186
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE TECHNICAL ANALYSIS INDICATED THAT THE PRODUCT IS IN COMPLIANCE WITH ORTHOFIX SPECIFICATIONS. ACCORDING TO THE INFO PROVIDED ON THE CASE AND AS A RESULT OF THE INVESTIGATION PERFORMED, ORTHOFIX CONCLUDES THAT THE SCREW WAS SUBJECT TO TORSIONAL OVERLOAD DURING INSERTION WHICH CAUSED IT TO BREAK. THE BREAKAGE IS RELATED TO THE ERRONEOUS SELECTION OF THE SCREW SIZE. THE BREAKAGE IS THEREFORE NOT PRODUCT RELATED. ORTHOFIX WOULD LIKE TO EMPHASIZE ONCE MORE THE IMPORTANCE OF METICULOUSLY FOLLOWING THE INSTRUCTIONS FOR USE (REF. TO PQEXF), WHERE DETAILED INFO ARE REPORTED REGARDING SCREW SELECTION AND THE CORRECT INSERTION TECHNIQUE. ORTHOFIX CONTINUES MONITORING THE PRODUCTS ON THE MARKET.

    Description of Event or Problem · 1

    DURING THE INSERTION, AN OSTEOTITE SCREW BROKE. THE TIP OF THE SCREW WAS LEFT IN THE PT HUMERUS. THE DEVICE FAILURE DID NOT HAVE ANY ADVERSE EFFECTS ON PT. MANUFACTURER REFERENCE NUMBERS: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OSTEOTITE CORTICAL SCREW, STERILE OSTEOTITE CORTICAL SCREW, STERILE JDW ORTHOFIX SRL 99-60138 11L06Z

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR