BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCREWDRIVER BIT AXSOS T20, AO FITITNG 5.0MM LOCKI

    MDR report key: 1861322 · Received October 4, 2010

    Report

    Report Number
    8031020-2010-00131
    Event Type
    Malfunction
    Date Received
    October 4, 2010
    Date of Event
    September 16, 2010
    Report Date
    September 21, 2010
    Manufacturer
    STRYKER OSTEOSYNTHESIS SELZACH
    Product Code
    LXH
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO HAS BEEN REQUESTED AND IF RECEIVED WILL BE PROVIDED ON A SUPPLEMENTAL REPORT. SAME PT AS MDR 8031020-2010-00138.

    Description of Event or Problem · 1

    THE RISK MANAGER REPORTED THE FOLLOWING, THE 2 SCREWDRIVERS BROKE AT THE TIGHTENING STEP. FOR ONE, THE TIGHTENING WAS PERFORMED WITH A MOTOR AND FOR THE OTHER, THE TIGHTENING WAS PERFORMED MANUALLY. THE SCREWS WERE NOT YET FULLY IMPLANTED INTO THE PLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCREWDRIVER BIT AXSOS T20, AO FITITNG 5.0MM LOCKI INSTRUMENT LXH STRYKER OSTEOSYNTHESIS SELZACH NA 01261U

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other