BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MANUAL ORTHOPEDIC SURGICAL INSTRUMENT

    MDR report key: 2041168 · Received April 6, 2011

    Report

    Report Number
    1030489-2011-00378
    Event Type
    Injury
    Date Received
    April 6, 2011
    Date of Event
    March 8, 2011
    Report Date
    June 14, 2011
    Manufacturer
    MEDTRONIC SOFAMOR DANEK INSTRUMENT MANUFACTURING
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    THE DRIVER WAS RETURNED FOR EVALUATION. VISUALLY CONFIRMED APPROXIMATELY 3MM OF TIP HAS BEEN BROKEN OFF, CONSISTENT WITH INTERFACE DURING USAGE, WITH PLASTIC DEFORMATION OF HEX FORM JUST BELOW FRACTURE. THE BROKEN OFF PORTION OF THE TIP WAS NOT RETURNED FOR ANALYSIS. TIP FRACTURE SURFACE ANALYSIS IS CHARACTERIZED AS A FAIRLY BRITTLE FRACTURE SURFACE WITH CIRCULAR MATERIAL FLOW, CONSISTENT WITH TORSIONAL OVERLOAD DURING USAGE. DIMENSIONAL INSPECTION OF THE DRIVER SHAFT CONFIRMS DIAMETER AND HEX FORM CONFORM TO PRINT SPECIFICATION. ADDITIONALLY, INSTRUMENT SHAFT TIP HARDNESS WAS INSPECTED AND FOUND TO BE WITHIN PRINT SPECIFICATION. THE ABOVE OBSERVATIONS ARE CONSISTENT WITH MISUSE, DUE TO OVERLOADING THE DRIVER DURING USAGE.

    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 ON A USER FACILITY MEDWATCH THAT THE TIP OF THE DRIVER BROKE OFF IN THE SCREW HEAD. THE TIP COULD NOT BE RETRIEVED AND THE SCREW COULD NOT BE ADVANCED SO THE SCREW POST WAS CUT OFF AT THE BONE LEVEL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A POSTERIOR SPINAL FUSION. IT WAS REPORTED THAT THE TIP OF THE DRIVER BROKE OFF IN THE BONE SCREW. NO FRAGMENTS OF THE DRIVER WERE LEFT IN THE PATIENT.

    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 SA09J167

    Patients

    Seq Age Sex Outcome Treatment
    1 00046 YR BONE SCREW