BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    METRX

    MDR report key: 3012669 · Received March 20, 2013

    Report

    Report Number
    1030489-2013-00786
    Event Type
    Malfunction
    Date Received
    March 20, 2013
    Date of Event
    February 15, 2013
    Report Date
    February 18, 2013
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. THE INFERIOR SHAFT IS BROKEN AT THE CENTERLINE OF THE PIVOT PIN HOLE. OPTICAL EXAMINATION IDENTIFIED A FAIRLY BRITTLE FRACTURE, WITH NO INDICATION OF FATIGUE. THE LOCATION AND AMOUNT OF FORCE REQUIRED IN ORDER TO INDUCE FRACTURE OF THE SHAFT IS CONSISTENT WITH OVERLOAD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE MICROPITUITARY'S BOTTOM JAW BROKE OFF, NOT IN THE PATIENT, IN AN UNKNOWN SPINAL SURGERY. ALTHOUGH USED IN SURGERY, THERE WERE NO PATIENT COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115495 METRX ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH WARSAW ORTHOPEDICS NA GZ06G083

    Patients

    Seq Age Sex Outcome Treatment
    1