BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCREWDRIVER, SELF-HOLDING, LONG 3.5 MM

    MDR report key: 1981638 · Received January 12, 2011

    Report

    Report Number
    9610622-2011-00009
    Event Type
    Malfunction
    Date Received
    January 12, 2011
    Date of Event
    December 19, 2010
    Report Date
    December 20, 2010
    Manufacturer
    STRYKER OSTEOSYNTHESIS KIEL
    Product Code
    LXH
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED, THE DOCTOR WENT TO USE THE SCREWDRIVER BUT IT WOULDN'T HOLD THE SCREW. AFTER LOOKING AT THE TIP OF THE SCREWDRIVER, WE NOTICED IT WAS BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCREWDRIVER, SELF-HOLDING, LONG 3.5 MM INSTRUMENT LXH STRYKER OSTEOSYNTHESIS KIEL NA KMW350703

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other