BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IM REAMER, AO FITTING BIXCUT 7,5X480 MM

    MDR report key: 2844938 · Received October 23, 2012

    Report

    Report Number
    9610622-2012-00474
    Event Type
    Malfunction
    Date Received
    October 23, 2012
    Date of Event
    October 9, 2012
    Report Date
    October 9, 2012
    Manufacturer
    STRYKER OSTEOSYNTHESIS KIEL
    Product Code
    HSB
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ONCE THE INVESTIGATION HAS BEEN COMPLETED ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT. ONCE THE INVESTIGATION HAS BEEN COMPLETED ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT. SAME EVENT AS MDR 9610622-2012-00476, MDR 9610622-2012-00475.

    Description of Event or Problem · 1

    CSSD PUT THE REAMERS THROUGH THE SONIC CLEANER AND WASHER THREE TIMES AND WEER STILL ABLE TO BEND THE REAMERS AND FLICK BLOOD OUT OF THEM. CSSD DOES NOT BELIEVE THEY CAN BE CLEANED AND ARE THEREFORE CONCERNED THAT THEY WERE USED IN PTS BEFORE THIS CASE AND MAY HAVE BEEN DIRTY WHEN THEY ARRIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IM REAMER, AO FITTING BIXCUT 7,5X480 MM INSTRUMENT HSB STRYKER OSTEOSYNTHESIS KIEL NA K905331

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other