BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANCE(R) DRILL BIT W/QUICK DISCONNECT

    MDR report key: 2112046 · Received June 2, 2011

    Report

    Report Number
    1043534-2011-00257
    Event Type
    Malfunction
    Date Received
    June 2, 2011
    Report Date
    July 15, 2011
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: NO CONCLUSION CAN BE DRAWN. THE PRODUCT WAS VISUALLY EXAMINED AND PHOTOGRAPHIC IMAGES WERE MADE. THE COMPLAINT WAS REVIEWED AND ANALYSIS SHOWED NO TREND FOR (B)(4), LOT NO: 399526. THE DEVICE HISTORY RECORD WAS REVIEWED; THE PRODUCT WAS MANUFACTURED TO SPECIFICATIONS AND MET ALL ACCEPTANCE/INSPECTION CRITERIA. (B)(4) - EVIDENCE THAT PRODUCT IN SPECIFICATION WHEN USED, UNDETERMINED.

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS NOT COMPLETE. TRENDS WILL BE EVALUATED. THIS IS A REPORTABLE MALFUNCTION. THIS EVENT CODE IS ADDRESSED IN THE PACKAGE INSERT. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE. THIS EVENT OCCURRED IN (B)(6).

    Additional Manufacturer Narrative · 1

    CORRECTED DATA: LOT NUMBER - ORIGINALLY REPORTED AS 069652592. SHOULD HAVE BEEN 399526. THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    ALLEGEDLY THE DRILL BIT BROKE OFF AND REMAINS IN THE PATIENT.

    Description of Event or Problem · 1

    ALLEGEDLY THE DRILL BIT BROKE OFF AND REMAINS IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVANCE(R) DRILL BIT W/QUICK DISCONNECT KNEE INSTRUMENT LXH WRIGHT MEDICAL TECHNOLOGY, INC. 399526

    Patients

    Seq Age Sex Outcome Treatment
    1