BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAPERED DRILL

    MDR report key: 2041185 · Received March 29, 2011

    Report

    Report Number
    9616696-2011-00044
    Event Type
    Injury
    Date Received
    March 29, 2011
    Date of Event
    February 4, 2011
    Report Date
    March 3, 2011
    Manufacturer
    STRYKER INSTRUMENTS CORK
    Product Code
    DZJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE BUR SUBJECT TO THIS INVESTIGATION WAS RETURNED TO THE MANUFACTURER FOR EVALUATION, IT WAS VISUALLY CONFIRMED THE TIP OF THE BUR WAS BROKEN FROM THE SHANK, HOWEVER, THE BROKEN PIECE WAS NOT RETURNED. THE BUR WAS MEASURED WHERE POSSIBLE AND ALL DIMENSIONAL SPECIFICATIONS WERE MET. MANUFACTURING RECORDS WERE REVIEWED, NO ISSUES WERE IDENTIFIED WHICH MAY HAVE CONTRIBUTED TO THIS EVENT. THE ROOT CAUSE IS UNDETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN SSRO (SAGITTAL SPLIT RAMUS OSTEOTOMY) PROCEDURE, THE TIP OF THE BUR BROKE. IT WAS ALSO REPORTED THAT ADDITIONAL GRINDING OFF THE SURROUNDING BONE USING ANOTHER BUR WAS REQUIRED TO RETRIEVE THE BROKEN PIECE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAPERED DRILL DZJ STRYKER INSTRUMENTS CORK 08080017

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention