BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUIDE SLEEVE F/HELICAL BLADE F/TFN

    MDR report key: 3143440 · Received June 3, 2013

    Report

    Report Number
    2530088-2013-00861
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Date of Event
    May 3, 2013
    Report Date
    May 8, 2013
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    FZX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: DURING AN IN-SERVICE PRESENTATION ON (B)(6) 2013 FOR THE TROCHANTERIC FIXATION NAIL (TFN), SEVERAL ITEMS WOULD NOT MATE WITH THE BLADE GUIDE SLEEVE FOR TROCHANTERIC FIXATION NAILS. IT DID NOT MATE WITH THE 11.0MM/3.2MM WIRE GUIDE, NOR THE HELICAL BLADE INSERTER. REPORTEDLY, IT APPEARED THAT THERE MAY A BURR OR SIZING ISSUE PREVENTING THE BLADE GUIDE SLEEVE FROM ACCEPTING THE ITEMS IT SHOULD. THIS IS REPORT 1 OF 3 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244828 GUIDE SLEEVE F/HELICAL BLADE F/TFN FZX SYNTHES BRANDYWINE 5220713

    Patients

    Seq Age Sex Outcome Treatment
    1