BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISPOSABLE PACK: STRYKER COMMAND & TPS DRILL

    MDR report key: 1934303 · Received November 24, 2010

    Report

    Report Number
    1651501-2010-00032
    Event Type
    Malfunction
    Date Received
    November 24, 2010
    Date of Event
    October 20, 2010
    Report Date
    November 24, 2010
    Manufacturer
    TAVA SURGICAL
    Product Code
    HWE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS HAS BEEN REPORTED TO THE MANUFACTURER FOR ASSISTANCE WITH THE INVESTIGATION INTO THIS EVENT. WHEN THE INVESTIGATION HAS BEEN COMPLETED AND/OR ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENT REPORT WILL BE FILED APPROPRIATELY.

    Description of Event or Problem · 1

    A DISPOSABLE SURGICAL INSTRUMENT PACKAGE THAT IS DISTRIBUTED BY US WAS BEING USED DURING A SURGICAL PROCEDURE WHERE THE TIP OF A SIDE CUTTING BURR BROKE OFF IN THE PT. THE SIDE CUTTING BURR WAS BEING USED TO PREPARE A PROXIMAL INTERPHALANGEAL JOINT FOR A PROSTHESIS. THE SURGEON DID NOT RETRIEVE THE BROKEN PIECE AND LEFT IT IN THE PT. NO PT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DISPOSABLE PACK: STRYKER COMMAND & TPS DRILL SURGICAL BONE DRILL AND BLADE HWE TAVA SURGICAL PID-DIS-STR NB2V3

    Patients

    Seq Age Sex Outcome Treatment
    1 Other