BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI PURPOSE OSTEOTOME, SLIGHT CURVED, 6MM WIDE

    MDR report key: 1697846 · Received May 12, 2010

    Report

    Report Number
    8010177-2010-00211
    Event Type
    Malfunction
    Date Received
    May 12, 2010
    Date of Event
    April 19, 2010
    Report Date
    April 19, 2010
    Manufacturer
    STRYKER OSTEOSYNTHESIS FREIBURG
    Product Code
    HWM
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS IN PROCESS BUT NOT YET COMPLETE.

    Description of Event or Problem · 1

    CORNER TIP OF BLADE IS FRACTURED OFF. DISCOVERED FRACTURED PRODUCT AFTER CLEANING AND STERILIZATION. UNK SOURCE OF BREAKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTI PURPOSE OSTEOTOME, SLIGHT CURVED, 6MM WIDE INSTRUMENT HWM STRYKER OSTEOSYNTHESIS FREIBURG NA E3

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK