BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TORQUE LIMITING SCREWDRIVER

    MDR report key: 1082453 · Received July 22, 2008

    Report

    Report Number
    8031020-2008-00058
    Event Type
    Malfunction
    Date Received
    July 22, 2008
    Date of Event
    June 24, 2008
    Report Date
    July 2, 2008
    Manufacturer
    STRYKER OSTEOSYNTHESIS SELZACH
    Product Code
    HXX
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    HOSP DISCARDED DEVICE. NO EVAL WILL BE PERFORMED. IF ADD'L INFO BECOMES AVAILABLE IT WILL BE SUBMITTED ON A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "TIP OF THE SCREWDRIVER BROKE OFF WHEN DRIVING A SCREW. TIP OF THE DRIVER WAS REMOVED FROM THE SCREW, AND NOT LEFT IN PT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TORQUE LIMITING SCREWDRIVER INSTRUMENT HXX STRYKER OSTEOSYNTHESIS SELZACH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other