BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KX+ FEM IMPACTOR

    MDR report key: 90507 · Received May 8, 1997

    Report

    Report Number
    2219689-1997-00236
    Event Type
    Malfunction
    Date Received
    May 8, 1997
    Report Date
    May 7, 1997
    Manufacturer
    HOWMEDICA
    Product Code
    HWA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUMMARY OF EVALUATION: HANDLE CRACKING IS TYPICALLY CAUSED BY REPETITIVE EXPOSURE TO ACIDIC CHEMICALS IN THE HOSPITAL DECONTAMINATION PROCESS, AND POSSIBLE, ACCELERATION BY MECHANICAL AND THERMAL EFFECTS.

    Description of Event or Problem · 1

    DURING ROUTINE INSTRUMENT CHECK, IT WAS NOTICED THAT THE IMPACTOR HANDLE WAS CRACKED. THIS EVENT DID NOT OCCUR DURING A SURGICAL PROCEDURE; THEREFORE, THERE WAS NO ADVERSE EFFECT TO ANY PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KX+ FEM IMPACTOR INSTRUMENT HWA HOWMEDICA NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other