BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTRAINED LINER INSERTER IMPACTOR TIP 28MM

    MDR report key: 2945759 · Received January 4, 2013

    Report

    Report Number
    2249697-2013-90038
    Event Type
    Malfunction
    Date Received
    January 4, 2013
    Date of Event
    December 11, 2012
    Report Date
    December 11, 2012
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    JDI
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN COMPLETED, THE EVAL SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    A PIECE OF PLASTIC BROKE OFF THE IMPACTOR NEAR THE THREAD WHEN IT WAS USED. ITEM BROKE AFTER SUCCESSFUL USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    5847 CONSTRAINED LINER INSERTER IMPACTOR TIP 28MM INSTRUMENT JDI STRYKER ORTHOPAEDICS MAHWAH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other