BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCREWDRIVER BIT ANCHORAGE T8, AO QUICK COUPLING

    MDR report key: 2843620 · Received October 25, 2012

    Report

    Report Number
    8031020-2012-00261
    Event Type
    Malfunction
    Date Received
    October 25, 2012
    Date of Event
    October 5, 2012
    Report Date
    October 11, 2012
    Manufacturer
    STRYKER OSTEOSYNTHESIS SELZACH
    Product Code
    HXX
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ONCE THE INVESTIGATION HAS BEEN COMPLETED ANY ADDITIONAL INFO WILL BE REPORTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THE OPERATING ROOM MGR, REPORTED THE FOLLOWING EVENT TO THE SALES REP: "DURING AN EXTRACTION OF A PLATE, THE SCREWDRIVER BITS FRACTURED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCREWDRIVER BIT ANCHORAGE T8, AO QUICK COUPLING INSTRUMENT HXX STRYKER OSTEOSYNTHESIS SELZACH NA C101089-10-00

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other