BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

    MDR report key: 2132728 · Received June 17, 2011

    Report

    Report Number
    1030489-2011-00752
    Event Type
    Malfunction
    Date Received
    June 17, 2011
    Date of Event
    May 19, 2011
    Report Date
    July 14, 2011
    Manufacturer
    MEDTRONIC SOFAMOR DANEK INSTRUMENT MANUFACTURING
    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 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

    (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 DRILL BITS ARE BROKEN AT THE ROOT OF THE FLUTING. THE BROKEN PIECE WAS NOT RETURNED. 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.

    Additional Manufacturer Narrative · 1

    NO EVAL EXPLAIN CODE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE THE SURGEON WAS USING THE DRILL IN THE RAIL CUTTER GUIDE. UPON REMOVAL OF THE DRILL, IT WAS NOTED THAT THE TIP OF THE DRILL HAD BROKEN OFF. THE BROKEN FRAGMENT WAS RETRIEVED BY USING THE SUCTION DEVICE AND THERE WAS NO HARM TO THE PATIENT. THE SURGERY WAS COMPLETED WITHOUT FURTHER INCIDENT.

    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 UQ08F002

    Patients

    Seq Age Sex Outcome Treatment
    1