BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCREWDRIVER BIT AXSOS T15, AO FITTING 4.0MM LOCKI

    MDR report key: 1884514 · Received October 21, 2010

    Report

    Report Number
    8031020-2010-00139
    Event Type
    Malfunction
    Date Received
    October 21, 2010
    Date of Event
    September 23, 2010
    Report Date
    September 29, 2010
    Manufacturer
    STRYKER OSTEOSYNTHESIS SELZACH
    Product Code
    HTW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WILL NOT BE RETURNED FOR EVALUATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED, SURGEON WAS TIGHTENING LOCKING SCREW AND THE TIP BROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCREWDRIVER BIT AXSOS T15, AO FITTING 4.0MM LOCKI INSTRUMENT HTW STRYKER OSTEOSYNTHESIS SELZACH NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other