BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TWINFIX ULTRA - PK

    MDR report key: 3843629 · Received June 2, 2014

    Report

    Report Number
    1219602-2014-00165
    Event Type
    Malfunction
    Date Received
    June 2, 2014
    Date of Event
    April 24, 2014
    Report Date
    May 5, 2014
    Manufacturer
    MANSFIELD MANUFACTURING SITE
    Product Code
    MBI
    PMA / PMN Number
    K093228
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE BROKEN INSERTER WAS RETURNED FOR EVALUATION. A VISUAL EVALUATION FOUND THAT THE WELDS AT THE TIP/SHAFT INTERFACE AND THE HANDLE/SHAFT INTERFACE WERE INTACT. THE AREA WHERE THE SHAFT TRANSITIONS TO THE TIP IS INTACT BUT THE MAJORITY OF THE TIP HAS BEEN TWISTED OFF AND WAS REPORTED TO BE IN SITU INSIDE THE ANCHOR. SITE PREPARATION DETAILS AND PATIENT BONE QUALITY WERE NOT PROVIDED. THIS FAILURE IS INDICATIVE OF A TORSIONAL OVERLOAD AND IS NOT ATTRIBUTABLE TO THE MANUFACTURING PROCESS. NO FURTHER INVESTIGATION IS WARRANTED AT THIS TIME. (B)(4).

    Description of Event or Problem · 1

    DURING AN UNKNOWN PROCEDURE UTILIZING A TWINFIX ULTRA PK 4.5MM W/2 UB -WHT & BL, IT WAS REPORTED THAT WHILE SCREWING IN THE TWINFIX IMPLANT, THE METAL HEXAGONAL PART OF INSERTER BROKE AND WAS LEFT INSIDE THE IMPLANT AND THE PATIENT. IT WAS NOT REMOVED. ADEQUATE FIXATION WAS ACHIEVED WITH THIS ANCHOR. NO NEW ANCHOR WAS PLACED AND NO HOLES WERE LEFT EMPTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322442 TWINFIX ULTRA - PK TWINFIX ULTRA PK 4.5MM W/2 UB -WHT &BL MBI MANSFIELD MANUFACTURING SITE 72202595 50472653

    Patients

    Seq Age Sex Outcome Treatment
    1