BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECIMED CURVED IMPACTOR

    MDR report key: 2406766 · Received January 10, 2012

    Report

    Report Number
    1043534-2012-00001
    Event Type
    Malfunction
    Date Received
    January 10, 2012
    Date of Event
    October 25, 2011
    Report Date
    December 5, 2011
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    HWA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS A REPORTABLE MALFUNCTION. THE INVESTIGATION IS NOT COMPLETE. TRENDS WILL BE EVALUATED. THIS REPORT WILL BE UPDATED WHEN THE EVALUATION IS COMPLETE. THIS IS THE SAME EVENT AS 1043534-2012-00002. THIS EVENT OCCURRED IN (B)(6).

    Additional Manufacturer Narrative · 1

    CONCLUSION: NO CONCLUSION CAN BE DRAWN. THE COMPLAINT WAS REVIEWED. THE PRODUCT WAS NOT RETURNED.

    Description of Event or Problem · 1

    ALLEGEDLY AFTER THE SURGEON HIT THE IMPACTOR 5 TIMES, THE HANDLE BROKE. THIS CAUSED A 30 MIN DELAY IN SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECIMED CURVED IMPACTOR HIP INSTRUMENT HWA WRIGHT MEDICAL TECHNOLOGY, INC. 117446559

    Patients

    Seq Age Sex Outcome Treatment
    1