BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

    MDR report key: 1963028 · Received January 18, 2011

    Report

    Report Number
    1030489-2011-00059
    Event Type
    Malfunction
    Date Received
    January 18, 2011
    Date of Event
    December 20, 2010
    Report Date
    December 20, 2010
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DRILL IS MISSING A PORTION OF THE TIP. THE BROKEN PIECE WAS NOT RETURNED. THE TIP IS BROKEN AT 10MM FROM THE ROOT OF THE FLUTING. THE FRACTURE APPEARANCE IS DUCTILE. NO DEFECT WAS FOUND AT THE LEVEL OF THE BREAKAGE. THIS KIND OF FAILURE IS CONSISTENT WITH AN OVER-TORQUE OF THE INSTRUMENT DURING USE. WITH THE AVAILABLE INFORMATION THE ORIGIN OF THE OVER-LOAD HAS NOT BEEN DETERMINED. 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

    (B)(4). THE RAIL CUTTER HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. ANALYSIS RESULTS ARE NOT AVAILABLE AT THE TIME OF THIS REP ORT. A FOLLOW-UP REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE. A REVIEW OF THE DEVICE HISTORY RECORDS FOR THIS DEVICE WAS NOT POSSIBLE WITHOUT ADDITIONAL DEVICE INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE USING THE RAIL CUTTER, THE SURGEON NOTICED THAT, UPON REMOVAL OF THE DRILL, THE TIP OF THE DRILL HAD BROKEN OFF. THE RAIL CUTTER GUIDE AND THE THREE TEMPORARY FIXATION PINS WERE REMOVED AND THE FRAGMENT OF THE DRILL BIT WAS LOCATED AND REMOVED USING A PAIR OF LONG TOOTHED FORCEPS. THE SURGEON WAS ABLE TO CONTINUE THE OPERATION AND FELT THERE HAD BEEN NO ADVERSE AFFECT ON THE PROCEDURE OR THE PATIENT AS A RESULT OF THIS INCIDENT. 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 8086-0100

    Patients

    Seq Age Sex Outcome Treatment
    1