BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

    MDR report key: 2210565 · Received August 12, 2011

    Report

    Report Number
    1030489-2011-01050
    Event Type
    Malfunction
    Date Received
    August 12, 2011
    Date of Event
    July 12, 2011
    Report Date
    July 14, 2011
    Manufacturer
    MEDTRONIC SOFAMOR DANEK INSTRUMENT MANUFACTURING
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. WE ARE UNABLE TO DETERMINE THE CAUSE OF THE EVENT. DEVICE HISTORY RECORDS WERE REVIEWED. NO DOCUMENTATION WAS FOUND THAT WOULD INDICATE A NON-CONFORMANCE TO SPECIFICATIONS.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. IT WAS VISUALLY CONFIRMED THAT THE INSTRUMENT CABLE IS DISASSEMBLED, AND THE ATTACHMENT HEAD, CABLE ADJUSTMENT SCREW, AND WASHERS ARE MISSING AND NOT RETURNED FOR ANALYSIS. UNABLE TO FUNCTIONALLY EVALUATE FLEX ARM RIGIDITY DUE TO DISASSEMBLY OF THE INSTRUMENT. INCONCLUSIVE; UNABLE TO DETERMINE ROOT CAUSE OF THE EVENT FROM THE AVAILABLE INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE FLEX ARM COULD NOT BE FIXED TIGHTLY. WHEN IT WAS TRYING TO FIND OUT THE REASON WHY IT COULD NOT BE TIGHTENED, THE INSTRUMENT WAS DISASSEMBLED. BUT THE SURGICAL PROCEDURE WAS NOT AFFECTED. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ORTHOPEDIC MANUAL SURGICAL INSTRUMENT ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH MEDTRONIC SOFAMOR DANEK INSTRUMENT MANUFACTURING NA MY10K001

    Patients

    Seq Age Sex Outcome Treatment
    1