BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNTHES DRILL BIT

    MDR report key: 3652828 · Received February 25, 2014

    Report

    Report Number
    MW5034751
    Event Type
    Other
    Date Received
    February 25, 2014
    Date of Event
    January 9, 2014
    Report Date
    February 24, 2014
    Manufacturer
    SYNTHES, INC
    Product Code
    HTW
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE ORTHOPEDIC SURGEON WAS PERFORMING A COMPLEX ANKLE FRACTURE REPAIR. DURING THE DRILLING PROCEDURE, A PIECE OF THE DRILL BIT BROKE OFF IN THE PT'S RIGHT ANKLE; THE DISTAL TIBIA. PRIOR TO CLOSING THE PROCEDURE, THE SURGEON ELECTED TO LEAVE THE DRILL BIT IN PLACE, TOTALLY EMBEDDED IN THE BONE. THIS ISSUE WAS EXPLAINED TO THE PT. ADDITIONALLY EXPLAINED TO THE PT, WAS THE TACT THAT THIS WOULD NOT LIKELY CAUSE THE PT ANY PROBLEMS. REMOVING THIS DRILL BIT WOULD HAVE CAUSED MORE EXTENSIVE DAMAGE TO THE BONE AND THE SURGEON DID NOT WANT TO RISK THE CHANCE. DIAGNOSIS OR REASON FOR USE: PLACEMENT OF A SCREW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115409 SYNTHES DRILL BIT DRILL BIT HTW SYNTHES, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Other