BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN ZIMMER DRILL BIT

    MDR report key: 1162842 · Received September 9, 2008

    Report

    Report Number
    1822565-2008-00582
    Event Type
    Malfunction
    Date Received
    September 9, 2008
    Date of Event
    August 7, 2008
    Report Date
    August 8, 2008
    Manufacturer
    ZIMMER, INC.
    Product Code
    HTW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE ALLEGED COMPLAINT REFERS TO THE SURGEON PERFORMING INTRAMEDULLARY NAILING OF A PERITROCHANTERIC HIP FRACTURE, WHEN THE DRILL BIT BROKE ON THE FIRST SCREW. IT WAS BROKEN WITHIN THE NAIL WITH ONE PIECE OF IT OUT OF THE MEDICAL CORTEX. THE DEVICE, LOT NUMBER, OR NAY MANUFACTURING INFORMATION WAS NOT SUPPLIED FOR REVIEW. NO PROBABLE CAUSE COULD BE DETERMINED THE INFORMATION PROVIDED. REVIEW OF THE DEVICE HISTORY RECORDS WAS ALSO NOT POSSIBLE AS THE PRODUCT AND/OR LOT NUMBERS REQUIRED FOR RETRIEVAL WERE UNAVAILABLE. IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECIFICATIONS. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT CONTRIBUTION TO THE REPORTED PROBLEM. BASED ON THE AVAILABLE INFORMATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADDITIONAL SUBSTANTIVE INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE DRILL BROKE WHILE THE SURGEON WAS PERFORMING INTRAMEDULLARY NAILING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN ZIMMER DRILL BIT HIP INSTRUMENT HTW ZIMMER, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR