BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SELF-DRILLING HALF PIN

    MDR report key: 1621913 · Received February 5, 2010

    Report

    Report Number
    8031020-2009-00149
    Event Type
    Malfunction
    Date Received
    February 5, 2010
    Date of Event
    June 29, 2007
    Report Date
    February 5, 2010
    Manufacturer
    STRYKER OSTEOSYNTHESIS SELZACH, STRYKER OSTEOSYNTHESIS
    Product Code
    JDW
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS PART OF A QUALITY SYSTEM IMPROVEMENT PLAN, STRYKER CORPORATION CONDUCTED A 7 YEAR RETROSPECTIVE MDR REVIEW TO ENSURE APPROPRIATE MDR REPORTING DECISIONS. EVENTS REPORTED TO STRYKER FROM 7/1/2006 TO 7/1/2008. WERE THE SCOPE OF THIS RETROSPECTIVE REVIEW. THESE EVENTS ARE PART OF A RETROSPECTIVE SUMMARY REPORT BEING SUBMITTED UNDER EXEMPTION #(B)(4). THERE ARE 2 EVENTS ASSOCIATED WITH THIS EVENT TYPE (DEVICE BROKE OR DISASSEMBLED DURING USE) AND PRODUCT CODE (JDW).

    Description of Event or Problem · 1

    DEVICE BROKE OR DISASSEMBLED DURING USE. WHEN APPLYING DRILLING FORCE ON THE ITEM, THE ITEM BROKE AT THE HEAD POSITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SELF-DRILLING HALF PIN IMPLANT JDW STRYKER OSTEOSYNTHESIS SELZACH, STRYKER OSTEOSYNTHESIS NA M22670

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other