BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MANUAL ORTHOPEDIC SURGICAL INSTRUMENT

    MDR report key: 1020246 · Received March 26, 2008

    Report

    Report Number
    1030489-2008-00148
    Event Type
    Malfunction
    Date Received
    March 26, 2008
    Date of Event
    February 22, 2008
    Report Date
    February 25, 2008
    Manufacturer
    WARSAW ORTHOPEDIC INC
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO MEDTRONIC FOR EVAL. UNABLE TO DETERMINE CAUSE OF THE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TIP OF THE TORX DRIVER BROKE OFF DURING TIGHTENING OF THE DOMINO CONNECTOR. THE BROKEN PIECE WAS RETRIEVED FROM THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MANUAL ORTHOPEDIC SURGICAL INSTRUMENT DRIVER LXH WARSAW ORTHOPEDIC INC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK