BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECT INTERNAL FRACTURE DRILL BIT

    MDR report key: 5540919 · Received April 1, 2016

    Report

    Report Number
    1822565-2016-00837
    Event Type
    Malfunction
    Date Received
    April 1, 2016
    Date of Event
    February 23, 2016
    Report Date
    June 4, 2016
    Manufacturer
    ZIMMER INC
    Product Code
    HTW
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    NO DEVICES OR PHOTOS WERE RECEIVED; THEREFORE THE CONDITION OF THE COMPONENTS IS UNKNOWN. DEVICE HISTORY RECORDS CANNOT BE REVIEWED SINCE THE LOT NUMBERS ARE UNKNOWN. THIS DEVICE IS USED FOR TREATMENT. THE INITIAL REPORTER OF THE EVENT WAS CONTACTED, AS IT WAS STATED THE PRODUCT WAS AVAILABLE FOR EVALUATION; HOWEVER, NO RESPONSE WAS RECEIVED. DUE TO THE LACK OF INFORMATION AND THE PRODUCT NOT BEING RETURNED, THIS COMPLAINT CANNOT BE CONFIRMED AND A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    THERE WAS NO PRODUCT RETURNED. LOT NUMBER WAS NOT PROVIDED THEREFORE, NO PHYSICAL EVALUATION COULD BE CONDUCTED. THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED DUE TO A LACK OF PRODUCT IDENTIFICATION. THE DEVICE IS USED FOR TREATMENT. DUE TO THE LACK OF INFORMATION AND THE PRODUCT NOT BEING RETURNED, THIS COMPLAINT CANNOT BE CONFIRMED AND NO PRODUCT ISSUE IS IDENTIFIED.

    Description of Event or Problem · 1

    IT IS REPORTED A DRILL BIT BROKE AND A SMALL PIECE OF THE DRILL BELIEVED TO BE ABOUT 5MM WAS MISPLACED. THE SURGICAL TEAM SEARCHED BUT COULD NOT LOCATE IT. AN X-RAY WAS TAKEN AND WAS FOUND TO BE NEGATIVE FOR ANY RETAINED PIECE. THE SURGEON BELIEVES THE PIECE WENT FLYING INTO THE AIR WHEN HE USED IT AGAINST A PIECE OF CEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    197248 ECT INTERNAL FRACTURE DRILL BIT HTW HTW ZIMMER INC N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR