BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MANUAL ORTHOPEDIC SURGICAL INSTRUMENT

    MDR report key: 1994070 · Received February 16, 2011

    Report

    Report Number
    1030489-2011-00136
    Event Type
    Malfunction
    Date Received
    February 16, 2011
    Date of Event
    January 18, 2011
    Report Date
    February 28, 2011
    Manufacturer
    MEDTRONIC SOFAMOR DANEK INSTRUMENT MANUFACTURING
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED FOR EVALUATION. INSTRUMENT TORQUE MECHANISM FUNCTIONALLY EVALUATED; TORQUE READINGS WERE TAKEN AND DETERMINED AVG TORQUE READING TO BE BELOW PRINT SPECIFICATION; 10 OF 36 INDIVIDUAL TORQUE READINGS WERE WITHIN PRINT SPECIFICATION. VISUALLY CONFIRMED DRIVER SHAFT BROKEN. UPON OPTICAL INSPECTION, CRACK APPEARS TO HAVE INITIATED AT STRESS RELIEF FILLET. MICROSCOPIC EXAMINATION OF FRACTURE REVEALED FAIRLY BRITTLE FRACTURE WITH ANGULATED SURFACE INDICATING A SIGNIFICANT TORSIONAL COMPONENT. RIVER LINES INDICATING CRACK INITIATED AT FILLET, WHICH PROPAGATED AROUND BEND OF DRIVER FRACTURE. THE AGE OF THE PART AND NATURE OF THE FRACTURE, IN CONJUNCTION WITH THE TORQUE READINGS SUGGEST ANTICIPATED WEAR AS THE POSSIBLE MECHANISM OF FAILURE. A REVIEW OF THE DEVICE HISTORY RECORDS DID NOT IDENTIFY ANY APPLICABLE NONCONFORMANCE TO SPECIFICATION.

    Additional Manufacturer Narrative · 1

    (B)(4). NEITHER THE DEVICE NOR APPLICABLE IMAGING FILMS WERE RETURNED TO THE MANUFACTURER FOR EVALUATION, THEREFORE, THE CAUSE OF THE EVENT CANNOT BE DETERMINED. DEVICE HISTORY RECORDS FOR THESE LOTS WERE REVIEWED. NO DOCUMENTATION WAS FOUND THAT WOULD INDICATE A NON-CONFORMANCE TO SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TIP BROKE OFF OF THE DRIVER. ALTHOUGH THIS EVENT OCCURRED DURING SURGERY, NO PATIENT COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A SPINAL SURGICAL PROCEDURE. IT WAS REPORTED THAT THE TIP OF THE DRIVER BROKE OFF WHILE IN USE. THE TIP WAS RETRIEVED FROM THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MANUAL ORTHOPEDIC SURGICAL INSTRUMENT ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH MEDTRONIC SOFAMOR DANEK INSTRUMENT MANUFACTURING NA BM05H016

    Patients

    Seq Age Sex Outcome Treatment
    1 SCREW