BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIZE 4-8 KEEL PUNCH GUIDE

    MDR report key: 1940979 · Received December 7, 2010

    Report

    Report Number
    2249697-2010-01692
    Event Type
    Malfunction
    Date Received
    December 7, 2010
    Date of Event
    November 18, 2010
    Report Date
    November 23, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    LXH
    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

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED: "HANDLE PROVED STIFF TO SLIDE. FOOT ON INSTRUMENT SNAPPED. ITEM WAS USED BEFORE BREAK NOTICED. PROCEDURE WAS COMPLETED AS ORIGINALLY PLANNED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIZE 4-8 KEEL PUNCH GUIDE INSTRUMENT LXH STRYKER ORTHOPAEDICS MAHWAH NA NZE01

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other