BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GRAY REVISION CEMENT FORCEPS

    MDR report key: 54696 · Received December 6, 1996

    Report

    Report Number
    2219689-1996-00294
    Event Type
    Malfunction
    Date Received
    December 6, 1996
    Date of Event
    October 23, 1996
    Report Date
    December 5, 1996
    Manufacturer
    HOWMEDICA INC.
    Product Code
    LZV
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE ROOT CAUSE OF THIS EVENT IS ATTRIBUTED TO MISUSE OF THE DEVICE BY THE USER. THE DEVICE IS INTENDED TO REMOVE PRE-LOOSENED CEMENT PARTICLES FROM THE FEMUR. THE DEVICE IS NOT INTENDED TO BREAK CEMENT FROM THE CEMENT MANTLE. CORRECTIVE ACTION HAS BEEN IMPLEMENTED TO PREVENT MISUSE AND THE LIKELIHOOD OF FAILURE IF MISUSED.

    Description of Event or Problem · 1

    THE TIP OF THE FORCEPS "BROKE OFF" DURING SURGERY. THERE WAS NO ADVERSE CONSEQUENCE TO ANY PT OR DELAY IN SURGICAL OR ANESTHESIA TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GRAY REVISION CEMENT FORCEPS INSTRUMENT LZV HOWMEDICA INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other