BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCREWDRIVER BLADE T10 AO FITTING

    MDR report key: 1981651 · Received January 12, 2011

    Report

    Report Number
    8031020-2011-00007
    Event Type
    Malfunction
    Date Received
    January 12, 2011
    Date of Event
    December 20, 2010
    Report Date
    December 20, 2010
    Manufacturer
    STRYKER OSTEOSYNTHESIS SELZACH
    Product Code
    LXH
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NA

    Description of Event or Problem · 1

    IT WAS REPORTED, THE SHAFT BROKE WHILE PUTTING IN SCREWS FOR THE SECOND OF TWO HOLES IN THE PLATE. PATIENT YOUNG WITH HARD BONE, NO TAP USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCREWDRIVER BLADE T10 AO FITTING INSTRUMENT LXH STRYKER OSTEOSYNTHESIS SELZACH NA U25943

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR