BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5.0MM FLEXIBLE SHAFT

    MDR report key: 3080484 · Received April 26, 2013

    Report

    Report Number
    8030965-2013-01983
    Event Type
    Malfunction
    Date Received
    April 26, 2013
    Date of Event
    April 1, 2013
    Report Date
    April 1, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    HTO
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Description of Event or Problem · 1

    DURING A RETROGRADE FEMORAL NAIL INSERTION ON (B)(6) 2013, A REAMER SHAFT SNAPPED AND BROKE AT THE BASE OF THE SHAFT. THIS OCCURRED DURING THE LAST PASS IN THE FEMORAL CANAL. THE SURGEON RETRIEVED THE BROKEN PIECE FROM THE BONE WITH NO ISSUES. THERE WAS NO EFFECT ON THE PATIENT. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    182852 5.0MM FLEXIBLE SHAFT HTO SYNTHES GMBH 2089471

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention