BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAIL CUTTER BIT, 1.5MM DIAM.

    MDR report key: 2231823 · Received September 1, 2011

    Report

    Report Number
    1030489-2011-01118
    Event Type
    Malfunction
    Date Received
    September 1, 2011
    Date of Event
    August 4, 2011
    Report Date
    August 4, 2011
    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). ANALYSIS OF THE RETURNED PRODUCT FOUND THAT THE DRILL BIT IS 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 CAN NOT BE 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A DISC REPLACEMENT PROCEDURE AT C5/6. DURING THE PROCEDURE, THE TIP OF THE DRILL BIT WAS BROKEN. THE BROKEN PIECE WAS RETRIEVED. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RAIL CUTTER BIT, 1.5MM DIAM. ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH MEDTRONIC SOFAMOR DANEK INSTRUMENT MANUFACTURING UQ09C007

    Patients

    Seq Age Sex Outcome Treatment
    1