BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MANUAL ORTHOPEDIC SURGICAL INSTRUMENT

    MDR report key: 1800048 · Received August 11, 2010

    Report

    Report Number
    1030489-2010-01044
    Event Type
    Malfunction
    Date Received
    August 11, 2010
    Date of Event
    July 12, 2010
    Report Date
    July 12, 2010
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    HXX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE DEVICE WAS RETURNED FOR EVALUATION. VISUALLY CONFIRMED TIP BROKEN. APPROX 3MM OF TIP HAS BEEN BROKEN OFF, CONSISTENT WITH INTERFACE DURING USE. FRACTURE SURFACE ANALYSIS REVEALED A FAIRLY BRITTLE FRACTURE SURFACE AND CIRCULAR MATERIAL FLOW, CONSISTENT WITH TORSIONAL OVERLOAD. A REVIEW OF THE DEVICE HISTORY RECORDS DID NOT IDENTIFY ANY APPLICABLE NONCONFORMANCE TO SPECIFICATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT UNDERWENT POSTERIOR SPINAL SURGERY. DURING THE SURGERY, THE TIP OF THE DRIVER BROKE. NO PT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MANUAL ORTHOPEDIC SURGICAL INSTRUMENT DRIVER HXX MEDTRONIC SOFAMOR DANEK NA BL07E001

    Patients

    Seq Age Sex Outcome Treatment
    1