BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRILL BIT 3.2X125MM AO FITTING

    MDR report key: 2566428 · Received May 2, 2012

    Report

    Report Number
    8031020-2012-00117
    Event Type
    Malfunction
    Date Received
    May 2, 2012
    Date of Event
    April 19, 2012
    Report Date
    April 19, 2012
    Manufacturer
    STRYKER OSTEOSYNTHESIS SELZACH
    Product Code
    KWH
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ONCE THE INVESTIGATION HAS BEEN COMPLETED ANY ADDITIONAL INFO WILL BE REPORTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    WHEN SURGEON DRILLED THE DRILL BIT WAS BROKE. OTHER DRILL BIT WAS USED, OPERATION WAS FINISHED SAFELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DRILL BIT 3.2X125MM AO FITTING INSTRUMENT KWH STRYKER OSTEOSYNTHESIS SELZACH NA K21232

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other