BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PCA UNIVERSAL INTERCONDYLAR DRILL GUIDE

    MDR report key: 39949 · Received September 5, 1996

    Report

    Report Number
    2219689-1996-00027
    Event Type
    Malfunction
    Date Received
    September 5, 1996
    Report Date
    August 30, 1996
    Manufacturer
    HOWMEDICA, INC
    Product Code
    HXY
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WHILE INSPECTING THE INSTRUMENT, IT WAS NOTICED, THE PEGS WERE BENT AND STARTING TO BREAK OFF. THIS EVENT DID NOT OCCUR DURING A SURGICAL PROCEDURE AND WAS NOTED THIS OCCURRED OVER TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PCA UNIVERSAL INTERCONDYLAR DRILL GUIDE INSTRUMENT HXY HOWMEDICA, INC NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA