BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

    MDR report key: 2850242 · Received November 29, 2012

    Report

    Report Number
    1030489-2012-02468
    Event Type
    Malfunction
    Date Received
    November 29, 2012
    Report Date
    December 14, 2012
    Manufacturer
    MEDTRONIC SOFAMOR DANEK INSTRUMENT MANUFACTURING
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): NEITHER THE DEVICE NOR APPLICABLE IMAGING FILMS WERE RETURNED TO THE MANUFACTURER FOR EVALUATION; THEREFORE, THE CAUSE OF THE EVENT CANNOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: THE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. THE INFERIOR SHAFT IS BROKEN AT THE PIVOT PIN. OPTICAL EXAMINATION IDENTIFIED A FAIRLY BRITTLE FRACTURE, WITH NO INDICATION OF FATIGUE. THE LOCATION AND AMOUNT OF FORCE REQUIRED IN ORDER INDUCE FRACTURE OF THE SHAFT IS CONSISTENT WITH OVERLOAD. THE ABOVE OBSERVATIONS ARE CONSISTENT WITH OVERLOAD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A PROCEDURE TO TREAT A LUMBAR HERNIATION. IT WAS REPORTED THAT THE LOWER TIP OF THE MICROPITUITARY BROKE OFF DURING USE. ALL FRAGMENTS WERE REMOVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED USING OTHER INSTRUMENT WITHOUT ANY FURTHER INCIDENTS. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ORTHOPEDIC MANUAL SURGICAL INSTRUMENT ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH MEDTRONIC SOFAMOR DANEK INSTRUMENT MANUFACTURING NA GZ10C097

    Patients

    Seq Age Sex Outcome Treatment
    1 00075 YR