BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

    MDR report key: 1934317 · Received December 21, 2010

    Report

    Report Number
    1030489-2010-01618
    Event Type
    Malfunction
    Date Received
    December 21, 2010
    Date of Event
    November 25, 2010
    Report Date
    November 25, 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

    (B)(4). THE RETURNED INSTRUMENT WAS FOUND BROKEN AT THE LEVEL OF THE CURTING TIP. NO DAMAGES OR DEFECTS HAVE BEEN IDENTIFIED AT THE LEVEL OF THE BREAKAGE. THE BREAKAGE IS CONSISTENT WITH AN OVERLOADING OF THE TIP DUE TO COMPRESSIVE AND BENDING LOADS. 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 WHILE PREPARING THE VERTEBRAL ENDPLATES FOR SURGERY, THE RING OF THE CURETTE TIP NEAR THE BASE OF THE METAL SHAFT BROKE. THERE WERE NO OBSERVABLE FRAGMENTS DISLODGED FROM THE INSTRUMENT AND NO ADVERSE EFFECTS WERE OBSERVED IN THE PATIENT. THE PROCEDURE WAS CONTINUED USING AN ALTERNATIVE TOOL. THE LOCATION OF THE BROKEN TIP WAS NOT ABLE TO BE DETERMINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ORTHOPEDIC MANUAL SURGICAL INSTRUMENT ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH MEDTRONIC SOFAMOR DANEK NA CB04M002

    Patients

    Seq Age Sex Outcome Treatment
    1