BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECT INTERNAL FRACTURE FIXATION DRILL

    MDR report key: 819892 · Received December 14, 2004

    Report

    Report Number
    1822565-2004-00143
    Event Type
    Malfunction
    Date Received
    December 14, 2004
    Date of Event
    November 4, 2004
    Report Date
    November 12, 2004
    Manufacturer
    ZIMMER, INC.
    Product Code
    HTW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: NO INFORMATION ON EITHER THE TRACEABILITY OR THE CONDITION OF THE DRILL IS KNOWN TO MAKE AN ENGINEERING ANALYSIS. THEREFORE, DUE TO NON-AVAILABILITY OF THE PRODUCT, NO ENGINEERING CAUSE COULD BE ATTRIBUTED. NO DEVICE WAS RECEIVED FOR EVALUATION. LOT NUMBER NOT REPORTED FOR DEVICE HISTORY VERIFICATION. THE SERVICE AGE AND WORKING CONDITION OF THIS DRILL BIT IS UNKNOWN.

    Description of Event or Problem · 1

    IT IS REPORTED THAT IN 2004, THE DRILL BIT BROKE OFF DURING SURGICAL PROCEDURE AND SURGEON WAS UNABLE TO REMOVE DRILL BIT PIECE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECT INTERNAL FRACTURE FIXATION DRILL DRILL BIT HTW ZIMMER, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR