BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    D/M H-GRIP INTRODUCER

    MDR report key: 1981619 · Received January 12, 2011

    Report

    Report Number
    2249697-2010-01943
    Event Type
    Malfunction
    Date Received
    January 12, 2011
    Date of Event
    December 7, 2010
    Report Date
    December 8, 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
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVAL OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MFR AT THIS TIME. IF ADD'L INFO BECOMES AVAILABLE THEN IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "INSERTER HANDLE WOULD NOT MATE WITH THE IMPLANT. REP SAID THAT IT NEVER WORKS TOGETHER. HAD TO IMPACT BY HAND INSTEAD. IS RETURNING THE ONE USED IN THIS CASE AND ANOTHER ONE THEY HAVE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 D/M H-GRIP INTRODUCER INSTRUMENT LXH STRYKER ORTHOPAEDICS MAHWAH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Required Intervention