BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MANUAL ORTHOPEDIC SURGICAL INSTRUMENT

    MDR report key: 4223259 · Received November 4, 2014

    Report

    Report Number
    1030489-2014-04201
    Event Type
    Malfunction
    Date Received
    November 4, 2014
    Date of Event
    October 6, 2014
    Report Date
    October 6, 2014
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4). 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

    CORRECTED INFORMATION: IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO: VISUALLY CONFIRMED APPROXIMATELY ~3MM OF INSTRUMENT TIP HAS BEEN BROKEN OFF, CONSISTENT WITH INTERFACE DURING USAGE. OPTICAL EXAMINATION OF THE FRACTURE SURFACE REVEALS A FAIRLY FLAT FRACTURE SURFACE AND CIRCULAR MATERIAL MOVEMENT, CONSISTENT WITH TORSIONAL OVERLOAD. THE ABOVE FINDINGS ARE CONSISTENT WITH TORSIONAL OVERLOAD. INSPECTION OF THE SHAFT DIAMETER AND MATERIAL HARDNESS CONFIRMED CONFORMANCE TO PRINT SPECIFICATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A POSTERIOR LUMBAR INTERBODY FUSION SURGICAL PROCEDURE. IT WAS REPORTED THAT THE TIP OF THE DRIVER BROKE OFF DURING TIGHTENING OF THE SETSCREW. THE BROKEN PIECE WAS RETRIEVED FROM THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    705022 MANUAL ORTHOPEDIC SURGICAL INSTRUMENT ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH MEDTRONIC SOFAMOR DANEK USA, INC NA PR11F005

    Patients

    Seq Age Sex Outcome Treatment
    1