BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRYKER DRILL BIT

    MDR report key: 1990018 · Received February 9, 2011

    Report

    Report Number
    MW5019387
    Event Type
    Malfunction
    Date Received
    February 9, 2011
    Date of Event
    February 7, 2011
    Report Date
    February 9, 2011
    Manufacturer
    STRYKER
    Product Code
    HTW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    A (B)(6) OLD MALE ADMITTED ON (B)(6) 2011 FOR LEFT TOTAL KNEE REPLACEMENT. WHEN ORTHO MD WAS DRILLING INTO THE BONE TO PLACE ANCHORING SCREWS, THE DRILL BIT BROKE IN TWO PIECES. BOTH PIECES WERE INTACT AND WERE REMOVED FROM THE SURGICAL FIELD. THE DRILL BIT WAS INSPECTED BY THE OPERATING ROOM TECH PRIOR TO SURGERY AND NO ISSUES WITH THE DRILL BIT WERE IDENTIFIED. OF NOTE, THE BONE WAS SCLEROTIC. PT TOLERATED THE PROCEDURE AND WAS DISCHARGED TO PACU IN STABLE CONDITION. NO NEGATIVE IMPACT ON THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRYKER DRILL BIT STRYKER DRILL BIT HTW STRYKER 6541-4-518 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR