BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MANUAL ORTHOPEDIC SURGICAL INSTRUMENT

    MDR report key: 1992021 · Received February 15, 2011

    Report

    Report Number
    1030489-2011-00131
    Event Type
    Malfunction
    Date Received
    February 15, 2011
    Date of Event
    January 13, 2011
    Report Date
    January 17, 2011
    Manufacturer
    MEDTRONIC SOFAMOR DANEK INSTRUMENT MANUFACTURING
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DRIVER WAS RETURNED FOR EVALUATION. VISUAL AND OPTICAL EXAMINATION REVEALS APPROXIMATELY ~3MM OF TIP HAS BEEN BROKEN OFF, CONSISTENT WITH INTERFACE DURING USAGE. PER THE REPORTED EVENT INFORMATION, REMOVAL OF OLD HARDWARE WOULD TEND TO REQUIRE HIGHER THAN TYPICAL TORQUE. FRACTURE SURFACE ANALYSIS REVEALS A FAIRLY FLAT, BRITTLE FRACTURE SURFACE AND CIRCULAR MATERIAL FLOW; ADDITIONALLY, PLASTIC DEFORMATION OF THE TIP IS NOTED JUST BELOW FRACTURE SURFACE, CONSISTENT WITH TORSIONAL OVERLOAD.

    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 NONCONFORMANCE TO SPECIFICATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A POSTERIOR SPINAL FUSION SURGICAL PROCEDURE. IT WAS REPORTED THAT SOMETIME POST-OP THE PATIENT UNDERWENT A REVISION SURGERY TO EXTEND THE CONSTRUCT. DURING THE REMOVAL OF THE OLD HARDWARE THE TIP OF THE DRIVER BROKE. THE TIP WAS RETRIEVED AND THE CASE CONTINUED WITHOUT INCIDENT. 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 OT09H007

    Patients

    Seq Age Sex Outcome Treatment
    1 SCREW