BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REDUCTION BALL END DRIVER

    MDR report key: 2231818 · Received September 1, 2011

    Report

    Report Number
    1030489-2011-01116
    Event Type
    Malfunction
    Date Received
    September 1, 2011
    Date of Event
    August 19, 2011
    Report Date
    October 17, 2011
    Manufacturer
    MEDTRONIC SOFAMOR DANEK INSTRUMENT MANUFACTURING
    Product Code
    HXX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE RETURNED DEVICE SHOWS THAT THE INSTRUMENT WAS RETURNED TO THE EOC WHERE QUALITY TECHNICIAN EVALUATION FOUND THAT THE HEX 3.5 MM BALL TIP WAS BROKEN AT THE START OF THE HEX 3.5 MM BALL TIP FEATURE (REDUCED SECTION BETWEEN THE SHAFT AND THE HEX 3.5 MM BALL TIP). THE BROKEN PART WAS NOT RETURNED FOR ANALYSIS. THE HEX 3.5 MM TIP IS TWISTED IN THE BONE SCREW UNTIGHTENING DIRECTION (CORRESPONDING TO THE BONE SCREW REMOVAL). THE TWIST AND THE BREAKAGE OF THE DRIVER ARE CONSISTENT WITH OVERLOADING APPLIED TO THE DRIVER DURING THE BONE SCREW REMOVAL DUE TO THE BONE SCREW STUCK IN BONE.

    Additional Manufacturer Narrative · 1

    (B)(4). NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. A REVIEW OF THE DEVICE HISTORY RECORDS FOR THIS DEVICE DID NOT REVEAL ANY NON-CONFORMANCES TO SPECIFICATION OR DEVIATIONS IN PROCEDURE WHICH MIGHT CONTRIBUTE TO THE REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. ANALYSIS RESULTS ARE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SPINAL PROCEDURE. DURING THE PROCEDURE, THE TIP OF THE SCREW DRIVER BROKE. THE BROKEN TIP WAS RETRIEVED AND THROWN AWAY. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REDUCTION BALL END DRIVER SCREWDRIVER HXX MEDTRONIC SOFAMOR DANEK INSTRUMENT MANUFACTURING RS09N012

    Patients

    Seq Age Sex Outcome Treatment
    1 00043 YR