BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TARGETING ARM

    MDR report key: 2090609 · Received April 19, 2011

    Report

    Report Number
    9610622-2011-00173
    Event Type
    Malfunction
    Date Received
    April 19, 2011
    Date of Event
    March 28, 2011
    Report Date
    April 5, 2011
    Manufacturer
    STRYKER OSTEOSYNTHESIS KIEL
    Product Code
    LXH
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: FUNCTIONAL CHECK - THE TARGETING ARM WAS TESTED WITH SAMPLE INSTRUMENT AND A SAMPLE NAIL ((B)(4) LEFT). ALL NAIL HOLES COULD BE PASSED BY A SAMPLE DRILL INSIDE SPEC. EVEN THOUGH THE TARGETING ARM MATERIAL IS CRACKED, THE FUNCTION WAS FULLY GIVEN. ALTHOUGH CRACKED THE RETURNED TARGETING ARM PASSED THE PRE-OPERATIVE FUNCTION TEST. THE ITEM WAS FUNCTIONAL IN SUCH A WAY NOT TO CAUSE SIGNIFICANT DAMAGES ON A CORRESPONDING NAIL RESPECTIVE NOT LEADING TO MISGUIDING. NO MFG FAULTS FOUND. EVAL REVEALED THAT THE FOUND CRACK IS LINKED TO THE DESIGN OF THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA OUR SALES REP THAT HE NOTICED DURING A SURGERY AFTER IMPLANTATION OF A NAIL THAT THE DEVICE SHOWED A FISSURE OF ABOUT 15 MM IN THE TRANSITION AREA FROM METAL TO CARBON. FURTHER HE NOTED THAT SURGERY WAS CONTINUED WITHOUT ALTERNATIVE DEVICE AND FINISHED WITHOUT DELAY AND WITH DESIRED RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TARGETING ARM INSTRUMENT LXH STRYKER OSTEOSYNTHESIS KIEL NA KP240724

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other