BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCREWDRIVER HEX 2.5MM AO FITTING

    MDR report key: 1190572 · Received October 2, 2008

    Report

    Report Number
    8031020-2008-00087
    Event Type
    Malfunction
    Date Received
    October 2, 2008
    Date of Event
    September 5, 2008
    Report Date
    September 5, 2008
    Manufacturer
    STRYKER OSTEOSYNTHESIS SELZACH
    Product Code
    HXX
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED. NO EVALUATION WILL BE PERFORMED. IF THE DEVICE OR ADDITIONAL INFORMATION BECOMES AVAILABLE, IT WILL BE REPORTED ON A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    PER THE (B) (6), THE SCREWDRIVER TIP BROKE OFF IN THE HEAD OF THE SCREW. DELAY IN SURGERY 30 MINS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCREWDRIVER HEX 2.5MM AO FITTING INSTRUMENT HXX STRYKER OSTEOSYNTHESIS SELZACH NA B76610

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other