BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MANUAL ORTHOPEDIC SURGICAL INSTRUMENT

    MDR report key: 1161465 · Received September 11, 2008

    Report

    Report Number
    1030489-2008-00509
    Event Type
    Malfunction
    Date Received
    September 11, 2008
    Report Date
    August 15, 2008
    Manufacturer
    WARSAW ORTHOPEDIC INC.
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO MEDTRONIC FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORDS FOUND NO DOCUMENTATION TO INDICATE A NON-CONFORMANCE TO SPECIFICATION. UNABLE TO DETERMINE CAUSE OF THE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE T20 DRIVER TIP WAS BROKEN OFF WHILE TIGHTENING THE LOCKING SCREW IN THE CONNECTOR. 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 BM04J005

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK